Torisel

Treats advanced renal cell carcinoma. NDA 22088, held by Pf Prism Cv. Temsirolimus.

As of Nov 14, 2026, NDA 22088 (Torisel), held by Pf Prism Cv, was first approved by FDA on May 30, 2007, with 18 approved supplements and 0 published complete response letters.

First approved: May 30, 2007
Review: Priority
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TORISEL is indicated for the treatment of advanced renal cell carcinoma.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


May 30, 2012	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Written Request Pediatric Amendment 1
Jul 9, 2010	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 26, 2010	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 30, 2007	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Medical Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Torisel25MG/ML (25MG/ML) · solution;intravenous	Temsirolimus	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Mar 23, 2018	Supplement 23Labeling · Standard review	Approved	Letter Label
Mar 23, 2018	Supplement 21Labeling · Standard review	Approved	Letter Label
May 22, 2017	Supplement 20Labeling · Standard review	Approved	Letter Label
Jul 27, 2016	Supplement 19Labeling · Standard review	Approved	Label Letter
Feb 26, 2015	Supplement 18Labeling · Standard review	Approved	Label Letter
Oct 7, 2014	Supplement 17Labeling · Standard review	Approved	Label Letter
Apr 7, 2014	Supplement 16Labeling · Standard review	Approved	Letter Label
Dec 20, 2013	Supplement 15Manufacturing · Priority review	Approved	None posted
May 30, 2012	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Written Request Pediatric Amendment 1
Jun 16, 2011	Supplement 12Labeling	Approved	Letter Label
Jun 16, 2011	Supplement 10Labeling	Approved	Letter Label
Jun 16, 2011	Supplement 7Labeling · Standard review	Approved	Letter Label
Jun 16, 2011	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 16, 2011	Supplement 4Labeling · Standard review	Approved	Letter Label
Jun 16, 2011	Supplement 2Labeling · Standard review	Approved	Letter Label
Jul 9, 2010	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 26, 2010	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 9, 2007	Supplement 1Manufacturing · Priority review	Approved	Letter Label
May 30, 2007	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 22088
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