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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA 202570/S-024
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`SUPPLEMENT APPROVAL
`FULFILLMENT OF POSTMARKETING REQUIREMENT
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`PF PRISM C.V.
`Attention: J. Nicole Earnhardt, Ph.D., R.A.C.
`Senior Manager, Worldwide Safety & Regulatory
`Pfizer, Inc.
`10646 Science Center Drive
`San Diego, CA 92121
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`Dear Dr. Earnhardt:
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`Please refer to your Supplemental New Drug Application (sNDA) dated August 29, 2017,
`received August 29, 2017, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for XALKORI (crizotinib) capsules, 200 mg and 250 mg.
`
`This Prior Approval supplemental new drug application revises the Clinical Pharmacology,
`Pharmacokinetics section of the package insert to incorporate results from a clinical
`pharmacology drug-drug interaction (DDI) trial studying strong CYP3A inhibitors used to fulfill
`postmarketing requirement 1789-6.
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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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`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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`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), with the
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`Reference ID: 4216993
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`

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`NDA 202570/S-024
`Page 2
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`addition of any labeling changes in pending “Changes Being 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 include 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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`FULFILLMENT OF POSTMARKETING REQUIREMENT(S)/COMMITMENT(S)
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`We have received your submission dated April 27, 2017, containing the final report for the
`following postmarketing requirement listed in the August 26, 2011, approval letter for this
`application.
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`1789-6
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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 inhibitor
`(e.g., ketoconazole)
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`We have reviewed your submission and conclude that the above requirement was fulfilled.
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`We remind you that there is postmarketing requirement listed in the September 14, 2015
`approval that is still open.
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`Reference ID: 4216993
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`

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`NDA 202570/S-024
`Page 3
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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 Ingrid Fan, Regulatory Project Manager, at (301) 796-5053.
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`Sincerely,
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`{See appended electronic signature page}
`
`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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`
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`Reference ID: 4216993
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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/
`----------------------------------------------------
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`JEFFERY L SUMMERS
`02/07/2018
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`Reference ID: 4216993
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