Andrew Krivoshik (Astellas)

Astel­las and Seagen's Pad­cev wins full FDA ap­proval, notch­ing ex­pand­ed la­bel in tough-to-crack urothe­lial can­cer

Two years af­ter Seagen and Astel­las won a con­di­tion­al FDA ap­proval to tar­get urothe­lial can­cer, the pair’s Pad­cev drug has been giv­en a full en­dorse­ment from reg­u­la­tors.

The FDA grant­ed full ap­proval and a la­bel ex­pan­sion for Pad­cev to treat pa­tients with ad­vanced or metasta­t­ic urothe­lial can­cer who aren’t el­i­gi­ble for cis­platin chemo, the com­pa­ny an­nounced on Fri­day. Pad­cev is now avail­able for sec­ond-line pa­tients, and the OK is the first for those who have pre­vi­ous­ly re­ceived im­munother­a­py and can­not re­ceive cis­platin, the com­pa­nies said.

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