Up­dat­ed: FDA punts PDU­FA date for an­oth­er in­di­ca­tion for As­traZeneca, Mer­ck­'s can­cer drug Lyn­parza

The FDA says not yet to two Big Phar­mas on their col­lab­o­ra­tive PARP in­hibitor’s newest in­di­ca­tion — it needs three more months to re­view.

As­traZeneca and Mer­ck said Thurs­day that the de­lay for the sup­ple­men­tal NDA is to “pro­vide fur­ther time for the full re­view of the sub­mis­sion.” The com­pa­nies said in a state­ment that they will con­tin­ue to work with FDA to fa­cil­i­tate the agency’s re­view.

The phar­mas’ ap­pli­ca­tion seeks ap­proval from the fed­er­al reg­u­la­tor for Lyn­parza, com­bined with ei­ther abi­raterone and pred­nisone or pred­nisolone, for pa­tients with metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer. Ac­cord­ing to pre­vi­ous guid­ance from As­traZeneca, the orig­i­nal PDU­FA date would’ve been be­fore the end of 2022, push­ing the new date in­to ear­ly next year.

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