Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While crit­i­ciz­ing the FDA for what may be some fa­voritism to­wards Mer­ck, Agenus on Fri­day of­fi­cial­ly pulled its ac­cel­er­at­ed BLA for its an­ti-PD-1 in­hibitor bal­stil­imab as a po­ten­tial sec­ond-line treat­ment for cer­vi­cal can­cer be­cause of the re­cent full ap­proval for Mer­ck’s Keytru­da in the same in­di­ca­tion.

The com­pa­ny said the BLA, which was due for an FDA de­ci­sion by Dec. 16, was with­drawn “when the win­dow for ac­cel­er­at­ed ap­proval of bal­stil­imab closed,” thanks to the con­ver­sion of Keytru­da’s ac­cel­er­at­ed ap­proval to a full ap­proval four months pri­or to its PDU­FA date.

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