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` NDA 210259/S-006
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` NDA 210259/S-007
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` SUPPLEMENT APPROVAL
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` FULFILLMENT OF POSTMARKETING REQUIREMENT
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`AstraZeneca UK Limited
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`c/o Acerta Pharma
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`Attention: Amanda Roodhouse
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`Director, Regulatory Science
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`121 Oyster Point Blvd
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`South San Francisco, CA 94080
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`Dear Ms. Roodhouse:
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`Please refer to your supplemental new drug applications (sNDAs) dated
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`September 24, 2019, received September 24, 2019, and your amendments, submitted
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`under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
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`CALQUENCE (acalabrutinib) capsules.
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`These Prior Approval supplemental new drug applications provide for the use of
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`CALQUENCE for the treatment of adult patients with chronic lymphocytic leukemia
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`(CLL) or small lymphocytic lymphoma (SLL).
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
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`Highlights of Prescribing Information. This waiver applies to all future supplements
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`containing revised labeling unless we notify you otherwise.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4523127
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` NDA 210259/S-006
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` NDA 210259/S-007
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` Page 2
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`Prescribing Information and Patient Package Insert), with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`reportable changes not included in the enclosed labeling.
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` Information on submitting SPL files using eList may be found in the guidance for
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` industry SPL Standard for Content of Labeling Technical Qs and As.2
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`The SPL will be accessible from publicly available labeling repositories.
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`Also, within 14 days, amend all pending supplemental applications that include labeling
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
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`annual reportable changes. To facilitate review of your submission(s), provide a
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`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
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`Word version. The marked-up copy should provide appropriate annotations, including
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`supplement number(s) and annual report date(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
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` new active ingredients (which includes new salts and new fixed combinations), new
` indications, new dosage forms, new dosing regimens, or new routes of administration
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` are required to contain an assessment of the safety and effectiveness of the product for
` the claimed indication in pediatric patients unless this requirement is waived, deferred,
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` or inapplicable.
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` Because this drug product for this indication has an orphan drug designation, you are
` exempt from this requirement.
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` FULFILLMENT OF POSTMARKETING REQUIREMENT
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`We have received your submission dated September 24, 2019, containing the final
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`report for the following postmarketing requirement listed in the October 31, 2017,
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`accelerated approval letter for NDA 210259.
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`PMR 3291-3 Conduct a clinical pharmacokinetic trial to determine an appropriate safe
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`dose of acalabrutinib in patients with severe hepatic impairment. This trial
`should be designed and conducted in accordance with the FDA Guidance
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`for Industry entitled “Pharmacokinetics in Patients with Impaired Hepatic
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4523127
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` NDA 210259/S-006
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` NDA 210259/S-007
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` Page 3
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`Function: Study Design, Data Analysis, and Impact on Dosing and
`Labeling.”
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` We have reviewed your submission and conclude that the above requirement was
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` fulfilled.
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`We remind you that there is a postmarketing requirement listed in the October 31, 2017,
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`accelerated approval letter that is still open.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter
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`requesting advisory comments, (2) the proposed materials in draft or mock-up form with
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`annotated references, and (3) the Prescribing Information 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 Promotion (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD
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`format. For more information about submitting promotional materials in eCTD format,
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`see the draft guidance for industry Providing Regulatory Submissions in Electronic and
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`Non-Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5 For more information
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`about submission of promotional materials to the Office of Prescription Drug Promotion
`(OPDP), see FDA.gov.6
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` 3 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
` version of a guidance, check the FDA guidance web page at
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` https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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` 6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
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`U.S. Food and Drug Administration
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`
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4523127
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` NDA 210259/S-006
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` NDA 210259/S-007
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` Page 4
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` REPORTING REQUIREMENTS
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` We remind you that you must comply with reporting requirements for an approved NDA
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` (21 CFR 314.80 and 314.81).
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`If you have any questions, call Jennifer Lee, Senior Regulatory Health Project Manager,
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`at (240) 402-4622.
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`Sincerely,
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`{See appended electronic signature page}
`
`
`Ann T. Farrell, MD
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`Director
`
`Division of Hematology Products
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`Office of Drug Evaluation I
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`• Content of Labeling
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`o Prescribing Information
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`o Patient Package Insert
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`U.S. Food and Drug Administration
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`
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4523127
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`ALBERT B DEISSEROTH
`11/21/2019 08:58:53 AM
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`Reference ID: 4523127
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`