Safety fears spur FDA to pause checkpoint combo studies by Bristol-Myers, Celgene
Two months after the FDA ordered Merck to slam the brakes on three Keytruda combo studies targeting multiple myeloma, alarmed regulators have followed up by posting a stop sign on enrolling any new patients in Bristol-Myers Squibb’s three rival studies concentrating on the same disease with the same combination approaches. And hours later Celgene $CELG added that it is being forced to pause 5 combo studies using AstraZeneca’s Imfinzi while getting slammed with a full hold on one other.
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