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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