Issue: July 10, 2015
June 01, 2015
1 min read

FDA to review Opdivo plus Yervoy for advanced melanoma

Issue: July 10, 2015
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The FDA has accepted for review the supplemental biologics license application for an Opdivo plus Yervoy regimen in patients with previously untreated advanced melanoma.

The new supplemental biologics license application includes data from CheckMate -069, which was presented at the ASCO Annual Meeting in Chicago and was the first randomized trial evaluating Opdivo (nivolumab, Bristol-Myers Squibb) and Yervoy (ipilimumab, Bristol-Myers Squibb) in patients with previously untreated advanced melanoma, according to a press release.

The combination treatment improved objective response rate in patients with BRAF wild-type mutation status compared with patients administered ipilimumab monotherapy, according to the release. There was an objective response rate of 61% in the nivolumab plus ipilimumab cohort, which included a 22% complete response rate. The safety profile was similar to previously reported studies on the combination therapy, according to the release.

The FDA granted priority review of the application, with an action date projected for Sept. 30, 2015. The FDA acceptance marks the first regulatory milestone for an immuno-oncology regimen in cancer.

“Our strategy has been to bring forth combination regimens of our immuno-oncology medicines to help bring the potential of long-term survival to patients,” Michael Giordano, MD, senior vice president, head of development, oncology, Bristol-Myers Squibb, said in the release. “The Opdivo+Yervoy regimen, in the CheckMate -069 trial, demonstrated greater efficacy beyond standard of care for patients with advanced melanoma.”

Both nivolumab and ipilimumab are approved as monotherapy by the FDA for treating unresectable or metastatic melanoma. The FDA also approved nivolumab in March for treating patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy, according to the release.

Adverse events reported with nivolumab include severe pneumonitis or interstitial lung disease, diarrhea or colitis, immune-mediated hepatitis, nephritis, renal dysfunction, hypothyroidism and hyperthyroidism and embryofetal toxicity, according to the release.