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` NDA 205552
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
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` Silver Spring MD 20993
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` ACCELERATED APPROVAL
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`Pharmacyclics, Inc.
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`Attention: Christine Salido
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`Executive Director, Regulatory Affairs
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`9995 East Arques Avenue
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`Sunnyvale, CA 94085-4521
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`Dear Ms. Salido:
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`Please refer to your New Drug Application (NDA) dated June 28, 2013, received June 28, 2013,
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`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
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`Imbruvica® (ibrutinib) Capsules, 140 mg.
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`We acknowledge receipt of your amendments dated May 6, 2013; May 13, 2013;
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`June 6, 2013; June 20, 2013; July 12, 2013; July 25, 2013 (2); July 26, 2013 (3);
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`July 30, 2013; August 1, 2013; August 2, 2013 (7); August 5, 2013(2); August 6, 2013;
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`August 7, 2013; August 9, 2013; August 12, 2013; August 13, 2013 (3); August 14, 2013 (11);
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`August 15, 2013; August 16, 2013; August 19, 2013; August 20, 2013; August 21, 2013;
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`August 23, 2013; August 26, 2013; August 29, 2013; August 30, 2013; September 4, 2013;
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`September 6, 2013; September 9, 2013 (3) September 11, 2013; September 12, 2013; September
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`17, 2013 (2); September 18, 2013; September 23, 2013; September 24, 2013; September 25,
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`2013; October 1, 2013; October 3, 2013(2); October 8, 2013; October 11, 2013;
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`October 16, 2013(3); October 18, 2013; October 23, 2013; October 24, 2013;
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`October 29, 2013(2); October 31, 2013 (3); November 5, 2013; November 12, 2013;
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`November 13, 2013(2).
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`This new drug application provides for the use of Imbruvica (ibrutinib) Capsules, 140 mg for the
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`treatment of patients with Mantle Cell lymphoma (MCL).
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved under the
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`provisions of accelerated approval regulations (21 CFR 314.500), effective on the date of this
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`letter, for use as recommended in the enclosed agreed-upon labeling text. Marketing of this drug
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`product and related activities must adhere to the substance and procedures of the referenced
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`accelerated approval regulations.
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`Reference ID: 3395788
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` NDA 205552
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` Page 2
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` We note that your November 12, 2013, submission includes final printed labeling (FPL) for
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` your: package insert, patient package insert. We have not reviewed this FPL. You are
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` responsible for assuring that the wording in this printed labeling is identical to that of the
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` approved content of labeling in the structured product labeling (SPL) format.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
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`patient package insert). Information on submitting SPL files using eLIST may be found in the
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`guidance for industry titled “SPL Standard for Content of Labeling Technical Qs and As” at
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible via publicly available labeling repositories.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We acknowledge your November 13, 2013, submission containing final printed carton and
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`container labels.
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`ADVISORY COMMITTEE
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`Your application for Imbruvica (ibrutinib) Capsules, 140 mg was not referred to an FDA
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`advisory committee because the application did not raise significant safety or efficacy issues in
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`the intended population.
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`ACCELERATED APPROVAL REQUIREMENTS
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`Products approved under the accelerated approval regulations, 21 CFR 314.510, require further
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`adequate and well-controlled studies/clinical trials to verify and describe clinical benefit. You
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`are required to conduct such studies/clinical trials with due diligence. If postmarketing
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`studies/clinical trials fail to verify clinical benefit or are not conducted with due diligence, we
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`may, following a hearing in accordance with 21 CFR 314.530, withdraw this approval. We
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`remind you of your postmarketing requirements specified in your submission dated
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`November 13, 2013. These requirements, along with required completion dates, are listed
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`below.
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`Reference ID: 3395788
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` NDA 205552
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` Page 3
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` PMR 2060-1
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`Continue follow-up of patients (on treatment and in protocol defined post-treatment follow-up)
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`and submit a final analysis report of trial PCYC-1104-CA with a minimum follow-up of
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`24 months for each patient. If 24 months follow-up is not possible for certain patients, provide
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`justification for each patient. In addition, submit detailed assessment information regarding all
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`sites of extranodal disease at baseline and follow-up, including assessments for response and
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`progression. Summarize extranodal disease characteristics at baseline and at time of progression.
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`Request further documentation as necessary from clinical trial sites in order to summarize the
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`details of the extranodal disease progression.
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`Final Protocol Submission: Complete 01/2013
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`Trial Completion:
`09/2014
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`Final Report Submission:
`03/2015
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`PMR 2060-2
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`Complete and submit the final results of the ongoing randomized, double-blind, placebo-
`controlled Phase 3 clinical trial (PCI-32765MCL3002) of ibrutinib in combination with
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`bendamustine and rituximab in patients with newly diagnosed mantle cell lymphoma.
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`Enrollment of approximately 520 patients is expected. The primary endpoint is progression-free
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`survival as assessed by investigators. Overall survival is a key secondary endpoint.
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`Final Protocol Submission: Completed 04/2013
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`Trial Completion:
`12/2018
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`Final Report Submission:
`03/2019
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`Submit final reports to this NDA as a supplemental application. For administrative purposes, all
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`submissions relating to this postmarketing requirement must be clearly designated “Subpart H
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`Postmarketing Requirement(s).”
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`Because this drug product for this indication has an orphan drug designation, you are exempt
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`from this requirement.
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`Reference ID: 3395788
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` NDA 205552
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` POSTMARKETING REQUIREMENTS UNDER 505(o)
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`Section 505(o)(3) of the FDCA authorizes FDA to require holders of approved drug and
`biological product applications to conduct postmarketing studies and clinical trials for certain
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` purposes, if FDA makes certain findings required by the statute.
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`We have determined that an analysis of spontaneous postmarketing adverse events reported
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` under subsection 505(k)(1) of the FDCA will not be sufficient to identify an unexpected serious
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` risk of inhibition of platelet function or assess a known serious risk of bleeding, including major
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` hemorrhagic events.
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`Furthermore, the new pharmacovigilance system that FDA is required to establish under section
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` 505(k)(3) of the FDCA will not be sufficient to assess this serious risk.
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`Therefore, based on appropriate scientific data, FDA has determined that you are required to
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`conduct the following:
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`PMR 2060-3
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`Determine the effect of a broad range of concentrations of ibrutinib on the potential to inhibit
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`platelet function by conducting in vitro studies. Assessment methods should include evaluation
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`of effects on platelet aggregation, including GPIb-mediated aggregation. Evaluation should
`include samples from subjects with and without concomitant conditions associated with platelet
`dysfunction (e.g., severe renal dysfunction, use of a concomitant anticoagulant, and use of
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`aspirin).
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`The timetable you submitted on November 13, 2013, states that you will conduct this study
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`according to the following schedule:
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`PMR 2060-4
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`Conduct an assessment and an analysis of data from clinical trials and all post-marketing sources
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` in order to characterize the risk of serious bleeding in patients treated with Imbruvica® ,
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` (ibrutinib) Capsules. The risks of special interest are major hemorrhagic events and their
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` potential association with concomitant use of anti-platelet and/or anticoagulant drugs. Major
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` hemorrhagic events are defined as any one of the following:
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`I. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal,
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`intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with
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`compartment syndrome,
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`Reference ID: 3395788
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`Draft Protocol Submission:
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`Final Protocol Submission:
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`Study Completion:
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`Final Report Submission:
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`06/2014
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`12/2014
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`06/2016
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`12/2016
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` NDA 205552
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` Page 5
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`II. Bleeding causing a fall in hemoglobin level of 20 g/L or more, or leading to transfusion
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` of two or more units of whole blood or red cells,
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` III. Bleeding resulting in a serious adverse drug experience [as per 21 CFR 314.80(a)]
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` This enhanced pharmacovigilance study will include:
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`1. Targeted and expedited surveillance with a guided collection form (as referenced in
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`Pharmacyclics’ Pharmacovigilance Plan dated August 23, 2013) to obtain additional salient
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`clinical and diagnostic information related to major hemorrhagic events.
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`2. Submission of Post-marketing 15-day Alert Reports for all initial and follow-up reports of
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`serious hemorrhagic adverse events from clinical trials and all post-marketing sources,
`including consumer reports, solicited reports, and foreign reports, utilizing the Standardized
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`Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ) – Haemorrhages.
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`3. Submission of interval and cumulative analyses, as well as line listing for all major
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`hemorrhagic events (utilizing the SMQ Haemorrhages) from clinical trials and all post-
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`marketing sources, including consumer reports, solicited reports, and foreign reports.
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`4. The interval and cumulative analyses should assess potential risk factors for cumulative
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`major hemorrhagic events identified from both clinical trials and all postmarketing sources,
`and an overall assessment about these events in patients treated with Imbruvica® (ibrutinib)
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`Capsules. In the overall assessment, discuss whether the data warrants further detailed
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`assessment, labeling changes and/or other communication about these adverse events.
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`Continue the study for a period of four years from the date of final protocol submission as noted
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`below. Prior to starting the study, submit for FDA review, a protocol describing how you will
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`conduct the study and report results, according to the timeline below.
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`The timetable you submitted on November 13, 2013, states that you will conduct this study
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`according to the following schedule:
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`Draft Protocol Submission:
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` Final Protocol Submission:
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` #1 Interim Report Submission
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` #2 Interim Report Submission
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` #3 Interim Report Submission
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` #4 Interim Report Submission
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` #5 Interim Report Submission
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` #6 Interim Report Submission
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` #7 Interim Report Submission
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` Study Completion:
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` Final Report Submission:
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`03/2014
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` 06/2014
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` 12/2014
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` 06/2015
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` 12/2015
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` 06/2016
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` 12/2016
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` 06/2017
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` 12/2017
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`06/2018
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`11/2018
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`Reference ID: 3395788
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` NDA 205552
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` Page 6
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` Finally, we have determined that only clinical trials (rather than a nonclinical or observational
` study) will be sufficient to identify unexpected serious risks of:
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` • Altered ibrutinib exposures (plasma concentrations) and resultant serious adverse
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` effects of treatment in patients with hepatic impairment, or with concomitant use of
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` Ibrutinib-induced Q-T prolongation and the potential for torsade de pointes.
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`•
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`Therefore, based on appropriate scientific data, FDA has determined that you are required to
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`conduct the following:
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`PMR 2060-5
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`Evaluate the effect of hepatic impairment on ibrutinib pharmacokinetics. Submit the final report
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`for trial PCI-32765CLL1006 entitled, “An Open-Label, Multicenter, Pharmacokinetic Study of
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`PCI-32765 in Subjects with Varying Degrees of Hepatic Impairment”.
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`The timetable you submitted on November 13, 2013, states that you will conduct this trial
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`according to the following schedule:
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`Final Protocol Submission: Completed 11/2012
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`Trial Completion:
`06/2014
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`Final Report Submission:
`12/2014
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`PMR 2060-6
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`Determine effect of a strong CYP3A Inducer on ibrutinib pharmacokinetics. Submit the final
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`report for trial PCI-32765CLL1010 entitled, “An Open-Label, Sequential Design Study to
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`Assess the Effect of Rifampin on the Pharmacokinetics of PCI-32765 in Healthy Subjects”.
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`The timetable you submitted on November 13, 2013, states that you will conduct this trial
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`according to the following schedule:
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`Final Protocol Submission: Completed 01/2013
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`Completed 01/2013
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`Trial Completion:
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`Final Report Submission:
`04/2014
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`PMR 2060-7
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`Determine the effect of ibrutinib on the QT/QTc interval in healthy subjects on one or more
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`therapeutic dose levels. Conduct and submit results of a thorough QT trial to evaluate the effects
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`of ibrutinib on the QT /QTc interval.
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`The timetable you submitted on November 13, 2013, states that you will conduct this trial
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`according to the following schedule:
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`Reference ID: 3395788
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` NDA 205552
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` Page 7
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` Draft Protocol Submission:
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` 03/2014
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` Final Protocol Submission: 06/2014
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`06/2015
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`Trial Completion:
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` Final Report Submission:
`12/2015
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` Submit protocols for our review and concurrence prior to initiating and in time to reach
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` agreement in advance of the final protocol submission date.
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`Submit the protocol to your IND 102688, with a cross-reference letter to this NDA. Submit all
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`final report(s) to your NDA. Prominently identify the submission with the following wording in
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`bold capital letters at the top of the first page of the submission, as appropriate: “Required
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`Postmarketing Protocol Under 505(o)”, “Required Postmarketing Final Report Under
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`505(o)”, “Required Postmarketing Correspondence Under 505(o)”.
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`Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of any
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`study or clinical trial required under this section. This section also requires you to periodically
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`report to FDA on the status of any study or clinical trial otherwise undertaken to investigate a
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`safety issue. Section 506B of the FDCA, as well as 21 CFR 314.81(b)(2)(vii) requires you to
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`report annually on the status of any postmarketing commitments or required studies or clinical
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`trials.
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`FDA will consider the submission of your annual report under section 506B and 21
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`CFR 314.81(b)(2)(vii) to satisfy the periodic reporting requirement under section
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`505(o)(3)(E)(ii) provided that you include the elements listed in 505(o) and 21 CFR
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`314.81(b)(2)(vii). We remind you that to comply with 505(o), your annual report must also
`include a report on the status of any study or clinical trial otherwise undertaken to investigate a
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`safety issue. Failure to submit an annual report for studies or clinical trials required under 505(o)
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`on the date required will be considered a violation of FDCA section 505(o)(3)(E)(ii) and could
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`result in enforcement action.
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`POSTMARKETING COMMITMENTS NOT SUBJECT TO THE REPORTING
` REQUIREMENTS UNDER SECTION 506B
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` We remind you of your postmarketing commitment:
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`PMC 2060-8
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`Collect additional dissolution profile data (n=12 at release and n=12 on stability) using USP
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`Apparatus Type 2 (Paddle) at 75 rpm in 3.0% w/v polysorbate 20 (Tween® 20) in 50 mM
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`phosphate buffer pH 6.8 at 37.0°C from at least ten drug product release batches and from the
`drug product stability-registration/ primary batches through 12 months of storage at the long-
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`term condition. Use the overall dissolution data that were collected from the drug product’s
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`release and stability batches to set the final dissolution acceptance criteria.
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`Reference ID: 3395788
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` NDA 205552
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` Page 8
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` Submit the final report with the complete dissolution information/data and a proposal for the
` dissolution acceptance under a supplement to the NDA within 15 months from action date.
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`11/2014
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`02/2015
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`Study Completion:
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`Final Report Submission:
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`Submit clinical protocols to your IND 102688 for this product. Submit nonclinical and
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`chemistry, manufacturing, and controls protocols and all postmarketing final reports to this
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`NDA. In addition, under 21 CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii) you should include a
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`status summary of each commitment in your annual report to this NDA. The status summary
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`should include expected summary completion and final report submission dates, any changes in
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`plans since the last annual report, and, for clinical studies/trials, number of patients entered into
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`each study/trial. All submissions, including supplements, relating to these postmarketing
`commitments should be prominently labeled “Postmarketing Commitment Protocol,”
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`“Postmarketing Commitment Final Report,” or “Postmarketing Commitment
`Correspondence.”
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`PROMOTIONAL MATERIALS
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`Under 21 CFR 314.550, you are required to submit, during the application pre-approval review
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`period, all promotional materials, including promotional labeling and advertisements, that you
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`intend to use in the first 120 days following marketing approval (i.e., your launch campaign). If
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`you have not already met this requirement, you must immediately contact the Office of
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`Prescription Drug Promotion (OPDP) at (301) 796-1200. Please ask to speak to a regulatory
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`project manager or the appropriate reviewer to discuss this issue.
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`As further required by 21 CFR 314.550, submit all promotional materials that you intend to use
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`after the 120 days following marketing approval (i.e., your post-launch materials) at least 30
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`days before the intended time of initial dissemination of labeling or initial publication of the
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`advertisement. We ask that each submission include a detailed cover letter together with three
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`copies each of the promotional materials, annotated references, and approved package insert
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`(PI)/Medication Guide/patient PI (as applicable).
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`Send each submission directly to:
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`OPDP Regulatory Project Manager
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotions (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`Reference ID: 3395788
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` NDA 205552
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` Page 9
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` METHODS VALIDATION
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`We have not completed validation of the regulatory methods. However, we expect your
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`continued cooperation to resolve any problems that may be identified.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with the reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`MEDWATCH-TO-MANUFACTURER PROGRAM
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`The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse
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` event reports that are received directly by the FDA. New molecular entities and important new
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` biologics qualify for inclusion for three years after approval. Your firm is eligible to receive
` copies of reports for this product. To participate in the program, please see the enrollment
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` instructions and program description details at
`http://www.fda.gov/Safety/MedWatch/HowToReport/ucm166910.htm.
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`POST- APPROVAL FEEDBACK MEETING
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` New molecular entities and new biologics qualify for a post-approval feedback meeting. Such
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` meetings are used to discuss the quality of the application and to evaluate the communication
`process during drug development and marketing application review. The purpose is to learn
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` from successful aspects of the review process and to identify areas that could benefit from
` improvement. If you would like to have such a meeting with us, call the Regulatory Project
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` Manager for this application.
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`PDUFA V APPLICANT INTERVIEW
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`FDA has contracted with Eastern Research Group, Inc. (ERG) to conduct an independent interim
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`and final assessment of the Program for Enhanced Review Transparency and Communication for
`NME NDAs and Original BLAs under PDUFA V (‘the Program’). The PDUFA V Commitment
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`Letter states that these assessments will include interviews with applicants following FDA action
`on applications reviewed in the Program. The purpose of the interview is to better understand
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`applicant experiences with the Program and its ability to improve transparency and
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`communication during FDA review.
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`You will be contacted by ERG to schedule the interview following this action on your
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`application; ERG will provide specifics about the interview process at that time. Your responses
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`during the interview will be confidential with respect to the FDA review team. ERG has signed a
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`non-disclosure agreement and will not disclose any identifying information to anyone outside
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`their project team. They will report only anonymized results and findings in the interim and final
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`assessments. Members of the FDA review team will be interviewed by ERG separately. While
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`your participation in the interview is voluntary, your feedback will be helpful to these
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`assessments.
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`Reference ID: 3395788
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`

`

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`Sincerely,
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`{See appended electronic signature page}
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`
`
`Richard Pazdur, M.D.
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`Director
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`Office of Hematology and Oncology Products
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`Center for Drug Evaluation and Research
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` NDA 205552
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` Page 10
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` If you have any questions, call CAPT Diane Hanner, Regulatory Project Manager, at
` (301) 796-4058.
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`ENCLOSURE(S):
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`Content of Labeling
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`Carton and Container Labeling
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`Reference ID: 3395788
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`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`RICHARD PAZDUR
`11/13/2013
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`Reference ID: 3395788
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`