Xalkori

Treats metastatic non-small cell lung cancer (NSCLC). NDA 202570, held by Pf Prism Cv. Crizotinib.

As of Nov 14, 2026, NDA 202570 (Xalkori), held by Pf Prism Cv, was first approved by FDA on Aug 26, 2011, with 29 approved supplements and 0 published complete response letters.

First approved: Aug 26, 2011
Review: Priority
Supplements approved: 29
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XALKORI is a kinase inhibitor indicated for the treatment of

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. ( 1.1, 2.1 )
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. ( 1.2, 2.3 ) o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


Sep 7, 2023	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Medication Guide Letter Label
Jul 14, 2022	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 14, 2021	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 30, 2018	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 28, 2017	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 11, 2016	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 14, 2015	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 20, 2013	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 26, 2011	Original applicationNew molecular entity · Priority review	Approved	Letter Review Summary Review Label

Products

2 strengths and forms


Xalkori200MG · capsule;oral	Crizotinib	RxReference drug
Xalkori250MG · capsule;oral	Crizotinib	RxReference drug

All 30 submissions, including labeling and manufacturing supplements


Sep 7, 2023	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Medication Guide Letter Label
Jul 14, 2022	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 22, 2021	Supplement 31Labeling · Standard review	Approved	Label
Jan 14, 2021	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 25, 2019	Supplement 28Labeling · Standard review	Approved	Label Letter
Dec 6, 2018	Supplement 27Labeling · Standard review	Approved	Label Letter
Nov 30, 2018	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 7, 2018	Supplement 24Labeling · Standard review	Approved	Letter
Feb 7, 2018	Supplement 23Labeling · Standard review	Approved	Label Letter
Jul 21, 2017	Supplement 21Labeling · Standard review	Approved	Label Letter
Apr 28, 2017	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 24, 2017	Supplement 20Labeling · Standard review	Approved	Letter Label
Apr 29, 2016	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 28, 2016	Supplement 18Labeling · Standard review	Approved	Letter Label
Mar 11, 2016	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 7, 2015	Supplement 15Manufacturing · Priority review	Approved	None posted
Sep 14, 2015	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 20, 2015	Supplement 13Labeling · Standard review	Approved	Letter Label
Aug 26, 2014	Supplement 12Manufacturing · Priority review	Approved	None posted
May 28, 2014	Supplement 11Labeling · Standard review	Approved	Letter Label
Feb 14, 2014	Supplement 10Manufacturing · Priority review	Approved	None posted
Nov 20, 2013	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 7, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Oct 7, 2013	Supplement 7Labeling · Standard review	Approved	Letter Label
Sep 13, 2013	Supplement 8Manufacturing · Priority review	Approved	None posted
Mar 12, 2013	Supplement 5Manufacturing · Priority review	Approved	None posted
Feb 28, 2013	Supplement 4Labeling · Standard review	Approved	Label Letter
Feb 24, 2012	Supplement 3Labeling · Standard review	Approved	Letter Label
Feb 17, 2012	Supplement 2Labeling · Standard review	Approved	Label Letter
Aug 26, 2011	Original applicationNew molecular entity · Priority review	Approved	Letter Review Summary Review Label

Identifiers

Application: NDA 202570
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