Opdivo Qvantig

For intermediate or poor risk advanced RCC. BLA 761381, held by Bristol-Myers Squibb. Nivolumab;Hyaluronidase-Nvhy.

As of Nov 13, 2026, BLA 761381 (Opdivo Qvantig), held by Bristol-Myers Squibb, was first approved by FDA on Dec 27, 2024, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 27, 2024
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OPDIVO QVANTIG is a combination of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of: Renal Cell Carcinoma (RCC)

adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab.
Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma.
adult patients with advanced RCC, as a first-line treatment in combination with cabozantinib.
adult patients with advanced RCC who have received prior anti-angiogenic therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Nov 24, 2025	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Oct 27, 2025	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 27, 2025	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 27, 2024	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Opdivo Qvantig600MG;10000UNITS PER5ML(120MG/2000UNITS PER ML) · injectable;subcutaneous	Nivolumab;Hyaluronidase-Nvhy	Rx

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 12, 2026	Supplement 12Labeling · Standard review	Approved	Label Label Letter
Nov 24, 2025	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Oct 27, 2025	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 27, 2025	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 23, 2025	Supplement 8Labeling · Standard review	Approved	Label Letter
Dec 27, 2024	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: Opdivo QvantigSep 9, 2025

Identifiers

Application: BLA 761381
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