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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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` NDA 202570/S-018
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`SUPPLEMENT APPROVAL/
`FULFILLMENT OF POSTMARKETING REQUIREMENT
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` PF PRISM C.V.
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`Attention: J. Nicole Earnhardt, Ph.D., RAC
`Senior Manager, Worldwide Safety & Regulatory
`Pfizer, Inc.
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`10646 Science Center Drive
`San Diego, CA 92121
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`Dear Dr. Earnhardt:
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`We refer to your New Drug Application (NDA) submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for XALKORI (crizotinib) Capsules, 250 mg and 200
`mg.
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`We have received your submission dated October 29, 2015, containing the final report for the
`following postmarketing requirement listed in the August 26, 2011, approval letter.
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`1789-7:
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`Conduct a multiple dose trial in patients to determine how to adjust the crizotinib
`dose when it is coadministered with a strong CYP3A inducer (e.g., rifampin).
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`We have reviewed your submission and conclude that the above requirement has been fulfilled.
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`We also refer to your supplemental New Drug Application (sNDA) dated November 20, 2015,
`received November 20, 2015, and your amendments. This Prior Approval supplemental new
`drug application proposes to update the Clinical Pharmacology, Pharmacokinetics subsection of
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` the package insert with data derived from Postmarketing Requirement (PMR) 1789-7 involving a
` multiple-dose crizotinib drug interaction study of CYP3A inducers. .
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`WAIVER OF HIGHLIGHTS SECTION
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of prescribing information.
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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
`text.
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`Reference ID: 3923173
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`

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`NDA 202570/S-018
`Page 2
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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
`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
`patient package insert), with the addition of any labeling changes in pending “Changes Being
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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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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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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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`Reference ID: 3923173
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`

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`NDA 202570/S-018
`Page 3
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`If you have any questions, call Ingrid Fan, Regulatory Project Manager, at (301) 796-5053.
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`Sincerely,
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`{See appended electronic signature page}
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`
`Jeffery Summers, M.D.
`Deputy Director for Safety
`Division of Oncology Products 2
`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: 3923173
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`

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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/
`----------------------------------------------------
`
`JEFFERY L SUMMERS
`04/28/2016
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`Reference ID: 3923173
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`