FDA accepts filing for Bristol-Myers Squibb's Opdivo, Yervoy regimen in advanced melanoma

Bristol-Myers Squibb announced Monday that the FDA accepted a filing seeking approval of the PD-1 inhibitor Opdivo (nivolumab) in combination with the CTLA-4 inhibitor Yervoy (ipilimumab) for patients with previously untreated advanced melanoma. The company noted that this "marks the first regulatory milestone for an immuno-oncology regimen for any cancer."

Michael Giordano, head of oncology development at Bristol-Myers Squibb, remarked "our strategy has always been to bring forth combination regimens of our immuno-oncology medicines to help bring the potential of long-term survival to patients." The drugmaker added that the FDA assigned priority review to the application and is expected to make a decision by September 30.

According to Bristol-Myers Squibb, the submission includes data from the Phase II CheckMate -069 study, which evaluated Opdivo plus Yervoy in patients with previously untreated advanced melanoma. Results showed that patients with BRAF wild-type mutation status treated with the regimen experienced improved objective response rate (ORR) as compared to patients administered Yervoy alone. The company indicated that the combination of Opdivo and Yervoy achieved an ORR of 61 percent, including a 22 percent complete response rate.

Bristol-Myers Squibb also recently presented Phase III results at the ASCO annual meeting demonstrating that the combination of Opdivo plus Yervoy significantly extended progression-free survival in patients with advanced melanoma, compared with either drug alone. However, the potential cost associated with use of the regimen was also questioned at the ASCO conference, with estimates that the drug combination will cost around $295 000 per patient over nearly one year.

Opdivo became the first PD-1 inhibitor available anywhere in the world following its launch in Japan last September. The drug has since gained accelerated approval by the FDA for the treatment of melanoma, while its indication was expanded in March to include the treatment of advanced squamous non-small-cell lung cancer in select patients. Meanwhile, Yervoy was approved in 2011 by regulators in the US, as well as in Europe and Australia, for the treatment of patients with advanced melanoma.

For related analysis, read ViewPoints: If cancer combinations are to be king, then Roche is first in line to the throne.

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