Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions; Adap­tate pulls in new cash for gam­ma delta T cell an­ti­bod­ies

Seagen is rid­ing the wave of two new pri­or­i­ty re­views straight to the FDA.

The Both­ell, WA-based biotech and their part­ners at Astel­las an­nounced Mon­day that two sup­ple­men­tal BLAs for Pad­cev had been ac­cept­ed by US reg­u­la­tors. FDA has set Aug. 17 as the PDU­FA date for the re­views.

“With our re­cent reg­u­la­to­ry sub­mis­sions, we in­tend to pro­vide the high­est lev­el of clin­i­cal ev­i­dence sup­port­ing Pad­cev use — over­all sur­vival da­ta from a ran­dom­ized Phase III tri­al — and ex­pand avail­abil­i­ty in mul­ti­ple coun­tries where there is un­met med­ical need,” said Astel­las on­col­o­gy chief An­drew Krivoshik.

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