UPDATED: FDA grants BMS's novel Opdivo accelerated approval for advanced melanoma
- The U.S. FDA on Monday granted accelerated approval to Bristol-Myers Squibb's anti-PD-1 monoclonal antibody, Opdivo, for treatment of unresectable melanoma and advanced melanoma in patients who no longer respond to drugs. "Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor," wrote the agency in its announcement.
- This is the second of the novel new PD-1 inhibitor drugs to be approved by the FDA in 2014, the first being Merck's Keytruda (approved for secondary treatment of melanoma back in September).
- Opdivo's approval comes more than three months before the drug's PDUFA date of March 30, 2015. As BioPharma Dive reported last week, it was expected to be the biggest drug launch of 2015, but Christmas seems to have come three days early for BMS. It will cost $12,500 per month for a typical patient.
BioPharma Dive reported last week that Opdivo was expected to have sales of $658 million next year and $7.122 billion by 2020—and that was assuming that approval would not be granted until 2015. All eyes are going to be on BMS's marketing strategy and the success of its sales push next year.
Even though Merck won the first U.S. approval of an anti-PD-1 monoclonal antibody this year, BMS's Opdivo has shown higher response rates in various cancer trials, which has led analysts to believe that it might become the go-to option in this new therapeutic class.
But as evidenced by this morning's stunning announcement by U.S. pharmacy benefits giant Express Scripts that it would exclusively offer AbbVie's newly-approved hep C drug over Gilead's Solvadi/Harvoni thanks to a discounted price tag, efficacy alone may not determine the winner in the immuno-oncology wars. Price matters, too, in a big way.