Near­ly a year af­ter sur­prise re­jec­tion, Im­munomedics re­turns to FDA

As last Christ­mas ap­proached, an­a­lysts an­tic­i­pat­ed a po­ten­tial block­buster from Im­munomedics. In­stead, they got phar­ma coal: a CRL.

Now, near­ly a year af­ter the FDA first spurned Im­munomedics’ lead drug, the ADC biotech is re­turn­ing to plead their case again. They have re­sub­mit­ted their BLA, seek­ing ac­cel­er­at­ed ap­proval for sac­i­tuzum­ab govite­can for triple-neg­a­tive metasta­t­ic breast can­cer.

Im­munomedics said the FDA not­ed man­u­fac­tur­ing is­sues in their re­jec­tion. Soon af­ter, it emerged that the agency had pre­vi­ous­ly cit­ed them for a breach of da­ta in­tegri­ty in the months lead­ing up to their PDU­FA, al­though the pub­licly re­leased re­port is heav­i­ly redact­ed and it re­mains un­clear if the da­ta breach was di­rect­ly con­nect­ed to the FDA re­jec­tion.

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