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EC grants approval to BMS Opdivo combo for gastroesophageal cancer
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EU approves Opdivo plus Yervoy for colorectal cancer
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EC green light for Opdivo plus Yervoy in metastatic colorectal cancer
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A group of advisers to the Food and Drug Administration this week recommended the agency maintain four of six recent cancer immunotherapy approvals despite a lack of evidence the medicines help patients live longer.
The positive votes, which took place over an unusual three-day meeting, could push the FDA to keep drugs from Roche, Bristol Myers Squibb and Merck & Co. on the market while the companies complete additional studies to confirm their benefit. The FDA typically, though not always, follows the advice of its advisory committees.
If the FDA does adhere to the panel votes, regulators could fuel further criticism that the agency isn t holding drugmakers to the terms of the accelerated approval pathway it s used to make new cancer drugs available quickly.