FDA slaps a hold on one of Amgen’s early-stage cancer drugs, raising cardiac tox concerns for a top prospect in the pipeline
Investigators involved in developing a ⭐⭐⭐⭐ cancer drug tapped as a bright prospect in Amgen’s early stage oncology pipeline have halted enrollment of new patients after signs of “cardiac toxicity” at a related drug with the same mechanism raised safety concerns at the FDA, prompting a clinical hold.
The pharma giant noted in an oncology update that their dose ranging study of the MCL1 inhibitor AMG 397 was placed on clinical hold by the agency, which prompted researchers to voluntarily halt enrollment in another early study of their other, more advanced, MCL1 program for AMG 176.
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