Inlyta

Treats advanced renal cell carcinoma (RCC). NDA 202324, held by Pf Prism Cv. Axitinib.

As of Nov 14, 2026, NDA 202324 (Inlyta), held by Pf Prism Cv, was first approved by FDA on Jan 27, 2012, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2012
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INLYTA is a kinase inhibitor indicated:

in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC.
as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. 1.1 First-Line Advanced Renal Cell Carcinoma INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced RCC. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Sep 22, 2022	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 4, 2020	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 27, 2012	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms


Inlyta1MG · tablet;oral	Axitinib	RxReference drug
Inlyta5MG · tablet;oral	Axitinib	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Jul 16, 2024	Supplement 16Labeling · Standard review	Approved	Label Letter
Sep 22, 2022	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 4, 2020	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 23, 2020	Supplement 10Labeling · Standard review	Approved	Letter Label
Aug 10, 2018	Supplement 8Labeling · Standard review	Approved	Letter Label
Jun 16, 2016	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 30, 2016	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 29, 2014	Supplement 3Labeling · Standard review	Approved	Label Letter
Aug 1, 2014	Supplement 2Labeling · Standard review	Approved	Letter Label
Sep 16, 2013	Supplement 1Labeling · Standard review	Approved	Letter Label
Jan 27, 2012	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 202324
Drugs@FDA: Overview at FDA
Company: PF PRISM CV

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters