FDA converts accelerated to full approval for Padcev-Keytruda combo in bladder cancer

The FDA on Fri­day grant­ed full ap­proval to Seagen and Astel­las Phar­ma’s Pad­cev (en­for­tum­ab ve­dotin-ejfv) in com­bo with Mer­ck’s Keytru­da (pem­brolizum­ab) for pa­tients with lo­cal­ly ad­vanced or metasta­t­ic urothe­lial can­cer.

The ap­proval comes a lit­tle less than two months af­ter thou­sands of ES­MO del­e­gates in Oc­to­ber gave a stand­ing ova­tion to con­fir­ma­to­ry tri­al da­ta show­ing the Pad­cev-Keytru­da com­bi­na­tion is the “new stan­dard of care” in first-line blad­der can­cer.

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