FDA drug record/Cancer/Opdivo Qvantig

FDA record · Cancer

Opdivo Qvantig (nivolumab; hyaluronidase-nvhy)

What FDA's own documents say about Opdivo Qvantig: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.

Sponsor
Bristol-myers Squibb
Application
BLA 761381
First approved
December 27, 2024
Status
Accelerated approval
Read from
20 FDA documents, 1,528 pages

What it is approved for

“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:”

Prescribing information, supplement 012 · PDF p. 1 · fda.gov ↗

Trials FDA reviewed

TrialClinicalTrials.govPhaseMentionsDocuments
CHECKMATE-648CA209-648NCT0314315331137 of 20
CHECKMATE-649CA209-649NCT0287211631077 of 20
CHECKMATE-025CA209-025NCT0166878431048 of 20
CHECKMATE-214CA209-214NCT0223174931037 of 20
CHECKMATE-67TCA209-67TNCT0481007831009 of 20
CHECKMATE-040CA209-040NCT016588781/2788 of 20
CHECKMATE-275CA209-275NCT023879962748 of 20

Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.

Results FDA reported

Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.

DFS

“The unstratified DFS hazard ratio estimate was 1.15 (95% CI: 0.74, 1.80).”

Prescribing information, supplement 001 · PDF p. 127 · fda.gov ↗

95%estimate was 1.15

DFS

“In an exploratory subgroup analysis in patients with PD-L1 expression of <1% (n=414), the unstratified DFS hazard ratio estimate was 0.83 (95% CI: 0.64, 1.08).”

Prescribing information, supplement 001 · PDF p. 127 · fda.gov ↗

95%estimate was 0.83

Safety

Most common adverse reactions

“ Most common adverse reactions (10%) with OPDIVO QVANTIG as monotherapy in patients with Renal Cell Carcinoma were: musculoskeletal pain, fatigue, pruritus, rash, hypothyroidism, diarrhea, cough, and abdominal pain.”

Prescribing information, supplement 012 · PDF p. 2 · fda.gov ↗

Adverse events the documents discuss most

Dosing on the label

“The recommended dosages of OPDIVO QVANTIG as monotherapy are presented in Table 1.”

Prescribing information, supplement 012 · PDF p. 7 · fda.gov ↗

“The recommended dosages of OPDIVO QVANTIG in combination with other therapeutic agents are presented in Table 2. Refer to the respective Prescribing Information for each therapeutic agent administered in combination with OPDIVO QVANTIG for the recommended dosage information, as appropriate.”

Prescribing information, supplement 012 · PDF p. 9 · fda.gov ↗

FDA documents read

DocumentDatePagesCopysha256
Approval letter (corrected)761381Orig1s000correctedltr.pdfJanuary 3, 20251159ef1f25e98d
Approval letter, supplement 008761381Orig1s008ltr.pdfMay 28, 20255c662eb1ad869
Prescribing information, supplement 008761381s008lbl.pdfJune 2, 2025152af9c7fa96a3c
Prescribing information, original approval (corrected)761381Orig1s000correctedlbl.pdfJune 13, 2025155e16fac3ef454
Prescribing information, supplement 001761381s001lbl.pdfOctober 28, 2025166ece237679c21
Prescribing information, supplement 002761381s002lbl.pdfOctober 28, 2025166b6332b3b1b43
Approval letter, supplement 002761381Orig1s002ltr.pdfOctober 28, 202564e30496c0a37
Approval letter, supplement 001761381Orig1s001ltr.pdfOctober 31, 202555ad4a4c9a8ed
Administrative Correspondence761381Orig1s000AdminCorres.pdfNovember 13, 20251449e8531a5d97
Approval Letter761381Orig1s000Approv.pdfNovember 13, 202516e15adf6d3bf7
Chemistry Review761381Orig1s000ChemR.pdfNovember 13, 202533183295938a09
Prescribing Information (Label)761381Orig1s000Lbl.pdfNovember 13, 2025156f9efb8baa233
Multi-disciplinary Review761381Orig1s000MultidisciplineR.pdfNovember 13, 20252119b389075ebb3
Proprietary Name Review761381Orig1s000NameR.pdfNovember 13, 202535ea7b7bbbbf40
Officer/Employee List761381Orig1s000OEList.pdfNovember 13, 20253c1020aec229e
Other Reviews761381Orig1s000OtherR.pdfNovember 13, 202550071d73dbd650
Prescribing information, supplement 005761381s005lbl.pdfNovember 25, 202516942d6511be6e4
Approval letter, supplement 005761381Orig1s005ltr.pdfNovember 25, 20255c11c3c101cdc
Approval letter, supplement 012761381Orig1s012ltr.pdfMay 13, 2026414f0051f66af
Prescribing information, supplement 012761381s012lbl.pdfMay 18, 2026166a5fbddea2df7

Checked against FDA's copies on September 30, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.

Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.

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