/ ... -... ( ~ Ii U.S. FOOD & DRUG
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`ADMINISTRATION
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`NDA 202324/S-014
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` CORRECTED SUPPLEMENT APPROVAL
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`PF PRISM C.V. represented by Pfizer Manufacturing Holdings LLC
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`Attention: Melissa McMahon, MS
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`Director, Pfizer Global Regulatory Affairs
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`10646 Science Center Drive
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`San Diego, CA 92121
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`Dear Ms. McMahon:
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`Please refer to your supplemental new drug application (sNDA) dated
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`December 7, 2021, received December 7, 2021, and your amendments, submitted
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`under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
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`Inlyta (axitinib) tablets.
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`We also refer to the approval letter and label dated September 22, 2022 that was
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`subsequently mailed to you, which contained the following errors:
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`• The approval letter referenced the provision: Addition of ‘Section 2.5, Dose
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`Modification for Diarrhea; however, this section was removed from the USPI, so it
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`should not have been referenced in the letter. Instead, this information was
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`added to Section 2.2.
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`• Bavencio was misspelled
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`• The dates in the Recent Major Changes section of the USPI showed place
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`holders instead of actual dates.
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`This corrected action letter and label incorporates the corrections of the errors. The
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`effective date will remain September 22, 2022; the date of the original letter.
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`This Prior Approval supplemental new drug application provides for:
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`• Replacement of text with tables in Section 2.2, Dose Modification Guidelines
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`• Addition of dose modification for diarrhea for Inlyta in combination with avelumab
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`or pembrolizumab in Section 2.2.
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`• Addition of adverse event data in Section 6.1, Clinical Trial Experience
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`• Sections 2.4, Dose Modification for Hepatic Impairment, and
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`Reference ID: 5053445
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` NDA 202324/S-014
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` 5.11, Hepatotoxicity, were updated to be consistent with the sections of the
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` approved USPIs of Keytruda and Bavencio related to the combination use of
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` these products with Inlyta
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` • Final OS analysis data for study KEYNOTE-426 in Section 14.1
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` Inclusion of hepatotoxicity in Section 17, Patient Counseling Information
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` Inclusion of high blood pressure in Patient Information
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`•
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`•
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA’s automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information and Patient Package Insertwith the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`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
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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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
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`changes for this NDA, including CBE supplements for which the FDA has not yet issued
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`an action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
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`annual reportable changes. To facilitate review of your submission(s), provide a
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`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
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`supplement number(s) and annual report date(s).
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` 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
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 5053445
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` NDA 202324/S-014
`Page 3
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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
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and
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`Non-Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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`PATENT LISTING REQUIREMENTS
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`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
`submitted in a supplement require you to submit patent information for listing in the
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`Orange Book upon approval of the supplement. You must submit the patent information
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`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
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`applicable, to the FDA on Form FDA 3542 within 30 days after the date of approval of
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`the supplement for the patent information to be timely filed (see 21 CFR
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`314.53(c)(2)(ii)). You also must ensure that any changes to your approved NDA that
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`require the submission of a request to remove patent information from the Orange Book
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`are submitted to the FDA at the time of approval of the supplement pursuant to 21 CFR
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`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
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`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 5053445
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` NDA 202324/S-014
`Page 4
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` If you have any questions, call Kim J. Robertson, Senior Regulatory Health Project
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` Manager, at (301) 796-1441, or kim.robertson@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Daniel Suzman, MD
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`Supervisory Associate Director
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`Division of Oncology 1
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`Office of Oncologic Diseases
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S): Content of Labeling
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`o Prescribing Information
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`o Patient Package Insert
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 5053445
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`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.
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`/s/
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`DANIEL L SUZMAN
`09/29/2022 02:36:35 PM
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`Reference ID: 5053445
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