EU regulators approve Bristol-Myers Squibb's Opdivo for advanced melanoma

Bristol-Myers Squibb on Friday announced that the EU cleared Opdivo (nivolumab) for the treatment of unresectable or metastatic melanoma in adults, regardless of BRAF status. The approval, which includes both first-line and previously treated patients, marks the first granted by the European Commission for a PD-1 inhibitor in any cancer and follows a recent positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use.

The decision was based on data from the Phase III CheckMate-066 and CheckMate-037 studies. In the CheckMate-066 study involving previously untreated patients, the Opdivo group demonstrated a one-year survival rate of 73 percent, versus 42 percent for patients administered dacarbazine. Further, there was a 58-percent decrease in the risk of death for patients treated with Opdivo, while the objective response rate (ORR) was also significantly higher for Bristol-Myers Squibb's drug than for dacarbazine.

Meanwhile, in the CheckMate-037 trial, which enrolled patients previously treated with Bristol-Myers Squibb's Yervoy (ipilimumab), as well as a BRAF inhibitor if they were BRAF-mutation-positive, an ORR improvement of 32 percent was seen in the Opdivo arm versus 11 percent in the investigator's choice chemotherapy arm, with 87 percent of the responses ongoing in Opdivo-treated patients. The company noted that responses to Opdivo were demonstrated in patients with or without BRAF mutations and regardless of PD-L1 expression.

Opdivo was cleared by the FDA last December for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs. This past March, US approval was expanded to include the treatment of advanced, squamous non-small-cell lung cancer in patients who progressed on or after platinum-based therapy. For related analysis, see ViewPoints: Bristol-Myers Squibb set to cash in on speedy approval of Opdivo in lung cancer.

The company reported that Opdivo generated $40 million in worldwide revenue during the first quarter of this year.

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