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FDA Approves Opdivo as Single Agent for Melanoma

doi: 10.1097/01.COT.0000479772.25205.6f
FDA Updates
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The Food and Drug Administration has approved Opdivo (nivolumab) as a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that works by targeting the immune system through the PD-1 immune checkpoint pathway.

Opdivo is also approved for: the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy; the treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) that has progressed during or after platinum-based chemotherapy (OT 11/25/15 issue); in combination with ipilimumab (marketed as Yervoy) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma (OT 11/10/15 issue); for the treatment of patients with squamous NSCLC that has progressed on or after platinum-based chemotherapy (OT 4/10/15 issue); and for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs (OT 1/25/15 issue).

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Approval Data

This approval for Opdivo is based on data from the randomized, double-blind Phase III CheckMate-066 trial of 210 patients with unresectable or metastatic BRAF wild type melanoma who received either Opdivo or dacarbazine. During an interim analysis, median overall survival was not reached for the patients receiving Opdivo and was 10.8 months for patients receiving dacarbazine.

Median progression-free survival was 5.1 months for patients who received Opdivo compared with 2.2 months for patients who received dacarbazine. And 34 percent of patients receiving Opdivo responded to treatment, compared with nine percent of patients receiving dacarbazine.

Last year, the CheckMate-066 trial was stopped early following a recommendation by the independent Data Monitoring Committee based on their analysis that showed evidence of superior overall survival in patients receiving Opdivo compared with the control arm.

As a result, patients in the trial were unblinded and patients who had received dacarbazine were allowed to receive Opdivo, according to a news release from the drug company, Bristol-Myers Squibb.

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Side Effects

Serious side effects reported by patients taking Opdivo were gamma-glutamyltranferase increase and diarrhea. Common adverse reactions included fatigue, musculoskeletal pain, rash, and pruritus.

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Clinical Quick Facts: Opdivo

Drug: Opdivo (nivolumab)

Approved Indication: Single-agent therapy for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma

Serious Side Effects: Gamma-glutamyltranferase increase and diarrhea

Common Side Effects: Fatigue, musculoskeletal pain, rash, and pruritus

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
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