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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 201023/S-011
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
`FULFILLMENT OF POSTMARKETING
`REQUIREMENTS
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`Sanofi US Services Inc.
`Attention: Donna Supko, Ph.D
`Senior Director, Regulatory Affairs
`500 Kendall Street
`Cambridge, MA 02142
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`Dear Dr. Supko:
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`Please refer to your Supplemental New Drug Application (sNDA) dated October 25, 2013,
`received October 25, 2013, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for JEVTANA® (cabazitaxel) Injection.
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`We acknowledge receipt of your amendments dated January 24, March 27, April 3, July 30,
`September 10, October 16, and October 28, 2014.
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`This “Prior Approval” supplemental new drug application proposes changes to the Highlights of
`Prescribing Information, Dosage and Administration, Drug Interactions, and Clinical
`Pharmacology section of the Prescribing Information, as well as revisions to the Patient Package
`Insert, based on data obtained from the TCD10870 study: “A Dose-Escalation Study of the
`Safety, Tolerability, and Pharmacokinetics of Cabazitaxel in Combination with Cisplatin
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`Administered every 3 Weeks in Patients with Advanced Solid Malignancies”.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text.
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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
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
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`patient package insert), with the addition of any labeling changes in pending “Changes Being
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`Reference ID: 3658913
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`NDA 201023/S-011
`Page 2
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`Effected” (CBE) supplements, as well as annual 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 industry titled
`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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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 includes labeling changes
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
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`POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS
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`UNDER SECTION 506B
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`We have received your submission dated October 25, 2013, containing the final report for the
`following postmarketing requirements listed in the June 17, 2010, approval letter.
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`Conduct a drug interaction trial to evaluate the effect of a strong CYP3A4
`inhibitor (e.g., ketoconazole) on the pharmacokinetics of cabazitaxel in cancer
`patients.
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`1649-7
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`1649-8
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`Conduct a drug interaction trial to evaluate the effect of a strong CYP3A inducer
`(e.g., rifampin) on the pharmacokinetics of cabazitaxel in cancer patients.
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`We have reviewed your submission and conclude that the above requirements were fulfilled.
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`We remind you that there are postmarketing requirements listed in the June 17, 2010, approval
`letter that are still open.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`Reference ID: 3658913
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`NDA 201023/S-011
`Page 3
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Charlene Wheeler, Regulatory Project Manager, at
`(301) 796-1141.
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`Sincerely,
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`{See appended electronic signature page}
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`
`Amna Ibrahim, M.D.
`Acting Director
`Division of Oncology Products 1
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
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`Reference ID: 3658913
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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/
`----------------------------------------------------
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`AMNA IBRAHIM
`11/19/2014
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`Reference ID: 3658913
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