Bristol-Myers wins $256K nod for Opdivo-plus-Yervoy in melanoma

Bristol-Myers Squibb ($BMY) continued its immuno-therapy march today with a combo approval in melanoma. The pairing of its older med Yervoy and new PD-1 cancer-fighter Opdivo won the FDA's green light for patients with advanced melanoma and a particular genetic variation.

The approval is based on data from a key clinical trial, which showed that more than half of patients who tested negative for a BRAF V600 mutation responded to the two-drug combo. About 60% of "BRAF wild-type" patients taking both drugs responded, compared with 11% of patients taking Yervoy alone; 17% of the two-drug patients had a complete response. The combo patients also lived a median of 4.2 months longer without their disease progressing.

The two-drug cocktail will cost $141,000 for a four-dose course of treatment, or $256,000 for a year's worth of therapy, Bristol-Myers says. The two drugs, purchased individually, carry a list price of almost $300,000.

Bristol-Myers is hoping that the cocktail approval will give Opdivo an advantage in melanoma over Merck & Co.'s ($MRK) competitor, Keytruda. The rival drugs were the first to be approved in a group of new-age immuno-oncology treatments, and they've been racing to gain market share--and to add new approvals in various patient groups and cancer types.

Opdivo beat Merck to a lung cancer indication earlier this year, but Merck could grab a broader approval in that disease later this week. Bristol-Myers has also unveiled impressive data for Opdivo in kidney cancer, where the immunotherapy topped Novartis' ($NVS) treatment Afinitor. Analysts have pegged Opdivo as the likely leader in the field, with EvaluatePharma expecting the drug to hit $8 billion by 2020.

Though Wednesday's approval is a nice win for Bristol-Myers, the company is hoping for a bigger one in melanoma, first for Opdivo and then for the two-drug combo. In August, the company's bid for first-line Opdivo use in melanoma was delayed till Nov. 27, putting it just a few weeks ahead of Keytruda's decision date for the same use.

Bristol-Myers is also looking for a first-line melanoma approval for the Opdivo-plus-Yervoy combination. And it recently unveiled data showing the combo works in lung cancer as well.

- read the Bristol-Myers release

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