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BMS to Seek Approval for Nivolumab in the US to Treat Advanced Melanoma
Following approval in Japan, Nivolumab will be evaluated by the FDA for melanoma therapy in the US.
Bristol-Myers Squibb Co said on Thursday it plans to seek U.S. marketing approval in the third quarter for its experimental cancer immunotherapy Opdivo as a treatment for advanced melanoma, which would be months sooner than Wall Street expected.
The company said it would seek approval to market the drug to patients who had previously been treated with Bristol-Myers' already approved melanoma drug Yervoy, which works through a different mechanism than Opdivo.
Mark Schoenebaum, an analyst with ISI Group, said many analysts had not expected Bristol-Myers to submit the marketing application until mid-2015, although he and some others had speculated an earlier filing was possible.
Opdivo was approved in Japan just this week to treat advanced melanoma, under license to Ono Pharmaceuticals.
Source: PubMed
