Proleukin

Treats metastatic renal cell carcinoma. BLA 103293, held by Chiron. Aldesleukin.

As of Nov 13, 2026, BLA 103293 (Proleukin), held by Chiron, was first approved by FDA on May 5, 1992, with 12 approved supplements and 0 published complete response letters.

First approved: May 5, 1992
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Proleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma. The treatment of adults with metastatic melanoma. 1.1 Metastatic Renal Cell Carcinoma Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC). 1.2 Metastatic Melanoma Proleukin is indicated for the treatment of adults with metastatic melanoma.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jan 9, 1998	Supplement 1021Efficacy (new indication or use) · Priority review	Approved	Letter
Jan 9, 1998	Supplement 1019Efficacy (new indication or use)	Approved	None posted
May 5, 1992	Original applicationNew molecular entity	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Proleukin22MIU/VIAL · vial	Aldesleukin	Rx

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 29, 2023	Supplement 5154Labeling · Standard review	Approved	Letter Label
May 17, 2019	Supplement 5146Labeling · Standard review	Approved	Letter
May 6, 2015	Supplement 5139Labeling · Standard review	Approved	None posted
Jul 30, 2012	Supplement 5130Labeling · Standard review	Approved	Letter Label
Dec 16, 2011	Supplement 5123Labeling · Standard review	Approved	Letter
Jul 19, 2011	Supplement 5114Labeling · Standard review	Approved	Letter
Jul 6, 2010	Supplement 5099Labeling · Standard review	Approved	None posted
Mar 17, 2010	Supplement 5088Labeling · Standard review	Approved	None posted
Apr 8, 2009	Supplement 5087Labeling · Standard review	Approved	None posted
Jun 27, 2000	Supplement 1029Labeling · Standard review	Approved	None posted
Jan 9, 1998	Supplement 1021Efficacy (new indication or use) · Priority review	Approved	Letter
Jan 9, 1998	Supplement 1019Efficacy (new indication or use)	Approved	None posted
May 5, 1992	Original applicationNew molecular entity	Approved	None posted

Identifiers

Application: BLA 103293
Drugs@FDA: Overview at FDA
Company: Chiron Corporation

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