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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 202570/S-021
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`Food and Drug Administration
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`Silver Spring MD 20993
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`NDA APPROVAL
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`PF PRISM C.V.
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`Attention: J. Nicole Earnhardt, Ph.D., R.A.C.
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`Senior Manager, Worldwide Safety & Regulatory
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`Pfizer, Inc.
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`10646 Science Center Drive
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`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 December 5, 2016,
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`received December 5, 2016, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for XALKORI (crizotinib) capsules, 200 mg and 250 mg capsules.
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`We also refer to our approval letter dated July 21, 2017, which inadvertently omitted the 200 mg
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`capsules in the first paragraph of the approval letter.
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`This replacement approval letter incorporates the correction of the error. The effective approval
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`date will remain July 21, 2017, the date of the original approval letter.
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`This supplemental application provides for updates to the Indication and Usage and Dosage and
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`Administration sections of the package insert to include information regarding the use of an
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`FDA-approved test for selection of patients whose metastatic NSCLC tumors are ROS1-positive.
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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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`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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`Reference ID: 4139571
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`NDA 202570/S-021
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`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
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`patient package insert), with the 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 this drug product for this indication has an orphan drug designation, 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: 4139571
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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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`NDA 202570/S-021
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`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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`Reference ID: 4139571
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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
`07/21/2017
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`Reference ID: 4139571
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`(
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