Bristol-Myers pulls back on accelerated approval of lung cancer combo drug

20 January 2017
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US pharma major Bristol-Myers Squibb (NYSE: BMY) was down 6.2% at $52.08 in after-hours trading on Thursday, after it revealed disappointing news on a proposed combination lung cancer drug, a move seen as an indication that rival Merck & Co (NYSE: MRK) is pulling ahead in this therapy sector with its drug Keytruda (pembrolizumab). Merck shares gained 4.7% to $63.15

Bristol-Myers yesterday announced that it has decided not to pursue an accelerated regulatory pathway for the combination of its PD-1 inhibitor Opdivo (nivolumab) in combination with CTLA-4 inhibitor Yervoy (ipilimumab)in first-line lung cancer in the USA based on a review of data available at this time. In order to protect the integrity of ongoing registrational studies, the company will not be providing additional details.

Jefferies analyst Jeffrey Holford, quoted by Reuters, said in a research note that he still expects the immunotherapy combination to be approved in the second half of 2018 and sees "no real change to valuation or estimates as a result of this update."

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