Yervoy

Treats unresectable or metastatic melanoma. BLA 125377, held by Bristol Myers Squibb. Ipilimumab.

As of Nov 13, 2026, BLA 125377 (Yervoy), held by Bristol Myers Squibb, was first approved by FDA on Mar 25, 2011, with 39 approved supplements and 0 published complete response letters.

First approved: Mar 25, 2011
Review: Priority
Supplements approved: 39
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma

Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab.
Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. Renal Cell Carcinoma (RCC)
Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 40 submissions below

Date	Submission	Status	Documents
May 23, 2025	Supplement 136Efficacy (new indication or use) · Priority review	Approved	Label Medication Guide
Apr 11, 2025	Supplement 133Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 8, 2025	Supplement 135Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 28, 2025	Supplement 132Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 15, 2023	Supplement 129Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 27, 2022	Supplement 122Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 11, 2022	Supplement 124Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 25, 2021	Supplement 121Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 2, 2020	Supplement 115Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 18, 2020	Supplement 112Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 26, 2020	Supplement 110Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
May 15, 2020	Supplement 109Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 10, 2020	Supplement 108Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 10, 2018	Supplement 96Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 16, 2018	Supplement 94Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 20, 2017	Supplement 86Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 21, 2017	Supplement 87Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Written Request Pediatric Amendment 1
Oct 28, 2015	Supplement 73Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 25, 2011	Original applicationNew molecular entity · Priority review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Yervoy3MG · injectable; injection	Ipilimumab	Rx

All 40 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 31, 2026	Supplement 140Labeling · Standard review	Approved	Letter Label
Jun 12, 2026	Supplement 138Labeling · Standard review	Approved	Medication Guide Letter Label
May 23, 2025	Supplement 136Efficacy (new indication or use) · Priority review	Approved	Label Medication Guide
Apr 11, 2025	Supplement 133Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 8, 2025	Supplement 135Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 28, 2025	Supplement 132Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 15, 2023	Supplement 129Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 23, 2022	Supplement 130Labeling · Standard review	Approved	Label Letter
May 27, 2022	Supplement 122Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 11, 2022	Supplement 124Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 25, 2022	Supplement 127Labeling · Standard review	Approved	Label Letter
Feb 25, 2022	Supplement 126Labeling · Standard review	Approved	Label Letter
May 25, 2021	Supplement 121Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 13, 2020	Supplement 119Labeling · Standard review	Approved	Letter Label
Oct 2, 2020	Supplement 115Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 18, 2020	Supplement 112Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 13, 2020	Supplement 111Labeling · Standard review	Approved	Label Letter
Jun 29, 2020	Supplement 106Labeling · Standard review	Approved	Review Letter Label
May 26, 2020	Supplement 110Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
May 15, 2020	Supplement 109Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 10, 2020	Supplement 108Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 20, 2019	Supplement 104Labeling · Standard review	Approved	Label Letter
May 8, 2019	Supplement 102Labeling · Standard review	Approved	Label Letter
Jul 10, 2018	Supplement 96Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 16, 2018	Supplement 94Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 8, 2018	Supplement 93Labeling · Standard review	Approved	Label Letter
Dec 13, 2017	Supplement 91Labeling · Standard review	Approved	Letter Label
Oct 20, 2017	Supplement 86Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 21, 2017	Supplement 87Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Written Request Pediatric Amendment 1
Mar 3, 2017	Supplement 84Labeling · Standard review	Approved	Letter
Oct 28, 2015	Supplement 73Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 17, 2015	Supplement 74Labeling · Standard review	Approved	Letter Label
Mar 19, 2015	Supplement 72Labeling · Standard review	Approved	Label Letter
Mar 16, 2015	Supplement 71REMS	Approved	None posted
Dec 5, 2013	Supplement 55Labeling · Standard review	Approved	Letter Label
May 22, 2013	Supplement 44Labeling · Standard review	Approved	Letter Label
Oct 26, 2012	Supplement 33Labeling · Standard review	Approved	Label Letter
Feb 16, 2012	Supplement 16Labeling · Standard review	Approved	Letter
Jul 28, 2011	Supplement 8Labeling · Standard review	Approved	None posted
Mar 25, 2011	Original applicationNew molecular entity · Priority review	Approved	Summary Review Review Letter Label

Identifiers

Application: BLA 125377
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

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