FDA slaps As­traZeneca's MCL-1 can­cer drug with a hold af­ter safe­ty is­sue — 2 years af­ter Am­gen axed a trou­bled ri­val

There are new ques­tions be­ing posed about a class of can­cer drugs in the wake of the sec­ond FDA-en­forced clin­i­cal hold in the field.

Two years af­ter the FDA hit Am­gen with a clin­i­cal hold on its MCL-1 in­hibitor AMG 397 fol­low­ing signs of car­diac tox­i­c­i­ty, As­traZeneca says that reg­u­la­tors hit them with a hold on their ri­val ther­a­py of the same class.

The phar­ma gi­ant not­ed on clin­i­cal­tri­als.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to al­low fur­ther eval­u­a­tion of safe­ty re­lat­ed in­for­ma­tion.”

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