NDA 217581
`
`
`
`NDA APPROVAL
`
`
`PF PRISM C.V.
`c/o Pfizer, Inc.
`Attention: Nicole Earnhardt Aldrich, PhD, RAC
`Director, Pfizer Global Regulatory Affairs
`10646 Science Center Drive
`San Diego, CA 92121
`
`Dear Dr. Earnhardt Aldrich:
`
`Please refer to your new drug application (NDA) dated and received November 29,
`2022, and your amendments, submitted under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for Xalkori (crizotinib) oral pellets.
`
`This NDA provides for the use of Xalkori (crizotinib) oral pellets for:
`
`
`• adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors
`are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-
`approved test.
`• pediatric patients 1 year of age and older and young adults with relapsed or
`refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.
`• adult and pediatric patients 1 year of age and older with unresectable, recurrent,
`or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.
`
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
`Highlights of Prescribing Information. This waiver applies to all future supplements
`containing revised labeling unless we notify you otherwise.
`
`CONTENT OF LABELING
`
`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
`
`Reference ID: 5239821
`
`

`

`NDA 217581
`Page 2
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information, Instructions for Use, and Medication Guide) as well as annual
`reportable changes not included in the enclosed labeling. Information on submitting SPL
`files using eLIST may be found in the guidance for industry SPL Standard for Content of
`Labeling Technical Qs and As.2
`
`The SPL will be accessible via publicly available labeling repositories.
`
`CARTON AND CONTAINER LABELING
`
`Submit final printed carton and container labeling that are identical to the enclosed
`carton and container labeling submitted on August 8, 2023, as soon as they are
`available, but no more than 30 days after they are printed. Please submit these labeling
`electronically according to the guidance for industry SPL Standard for Content of
`Labeling Technical Qs & As. For administrative purposes, designate this submission
`“Final Printed Carton and Container Labeling for approved NDA 217581.” Approval
`of this submission by FDA is not required before the labeling is used.
`
`DATING PERIOD
`Based on the stability data submitted to date, the expiry dating period for Xalkori
`(crizotinib) oral pellets shall be 24 months from the date of manufacture when stored at
`20°C to 25°C (68˚F to 77˚F); excursions permitted between 15˚C to 30˚C (59˚F to 86˚F)
`[see USP Controlled Room Temperature].
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`new active ingredients (which includes new salts and new fixed combinations), 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 in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because this drug product for this indication has an orphan drug designation, you are
`exempt from this requirement.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`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.
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5239821
`
`

`

`NDA 217581
`Page 3
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`Electronic Format—Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
`and the Prescribing Information, at the time of initial dissemination or publication,
`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
`Information and Instructions for completing the form can be found at FDA.gov.5
`
`METHODS VALIDATION
`
`We have not completed validation of the regulatory methods. However, we expect your
`continued cooperation to resolve any problems that may be identified.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`COMPENDIAL STANDARDS
`
` drug with a name recognized in the official United States Pharmacopeia or official
`National Formulary (USP-NF) generally must comply with the compendial standards for
`strength, quality, and purity, unless the difference in strength, quality, or purity is plainly
`stated on its label (see FD&C Act § 501(b), 21 USC 351(b)). FDA typically cannot share
`application-specific information contained in submitted regulatory filings with third
`parties, which includes USP-NF. To help ensure that a drug continues to comply with
`compendial standards, application holders may work directly with USP-NF to revise
`official USP monographs. More information on the USP-NF is available on USP’s
`website6.
`
` A
`
`
`3 For the most recent version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/media/128163/download.
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`6 https://www.uspnf.com/
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5239821
`
`

`

`NDA 217581
`Page 4
`
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`If you have any questions, contact Maritsa Stephenson, PharmD, BCPS, Regulatory
`Health Project Manager, by email at maritsa.stephenson@fda.hhs.gov.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Nicole Drezner, M.D.
`Deputy Division Director
`Division of Oncology 2
`Office of Oncologic Diseases
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE(S):
`• Content of Labeling
`o Prescribing Information
`o Medication Guide
`Instructions for Use
`o
`• Carton and Container Labeling
`
`
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5239821
`
`

`

`Signature Page 1 of 1
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`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/
`------------------------------------------------------------
`
`NICOLE L DREZNER
`09/07/2023 02:23:46 PM
`
`Reference ID: 5239821
`
`(
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