NDA 202324/S-011
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`PF Prism C.V.
`c/o Pfizer Manufacturing Holdings LLC
`Attention: Melissa J. McMahon, MS
`10646 Science Center Drive
`San Diego, CA 92121
`
`
`Dear Ms. McMahon:
`
`Please refer to your supplemental new drug application (sNDA) dated
`December 10, 2019, received December 10, 2019, and your amendments, submitted
`under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Inlyta
`(axitinib) Tablets.
`
`We also refer to the Supplement Request letter dated May 21, 2020, which requested
`updates to section 6.2 of the Precribing Information to include “Arterial (including aortic)
`aneurysms, dissections, and rupture.”
`
`This Prior Approval supplemental new drug application provides for updates to the Inlyta
`Prescribing Information to include a new indication for use of Inlyta in combination with
`avelumab or pembrolizumab for the first-line treatment of patients with advanced renal
`cell carcinoma. This supplement also provides for updates to section 6.2 of the
`Prescribing Information in response to the Supplement Request letter dated
`May 21, 2020.
`
`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
`
`Reference ID: 4619585
`
`

`

`NDA 202324/S-011
`Page 2
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`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information and 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.
`
`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 from publicly available labeling repositories.
`
`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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), 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).
`
`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.
`
`We are waiving the pediatric study requirement for this application because necessary
`studies are impossible or highly impracticable. Renal cell carcinoma is extremely rare in
`pediatric patients.
`
`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-
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
`
`
`
`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.
`3 For the most recent version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/media/128163/download.
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4619585
`
`

`

`NDA 202324/S-011
`Page 3
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`You must submit final promotional materials and Prescribing Information, accompanied
`by a Form FDA 2253, at the time of initial dissemination or publication
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`Instructions for completing the form can be found at FDA.gov.5
`
`All promotional materials that include representations about your drug product must be
`promptly revised to be consistent with the labeling changes approved in this
`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
`in your promotional materials should include prominent disclosure of the important new
`safety information that appears in the revised labeling. Within 7 days of receipt of this
`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, Clara Lee, PharmD, Regulatory Project Manager, at
`Clara.Lee@fda.hhs.gov or (240) 402-4809.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Amna Ibrahim, MD
`Deputy Director
`Division of Oncology 1
`Office of Oncologic Diseases
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE(S):
`• Content of Labeling
`o Prescribing Information
`o Patient Package Insert
`
`
`
`
`
`
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4619585
`
`

`

`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/
`------------------------------------------------------------
`
`AMNA IBRAHIM
`06/04/2020 01:06:23 PM
`
`Reference ID: 4619585
`
`