Seagen, Mer­ck­'s Pad­cev-Keytru­da com­bo snags FDA ac­cel­er­at­ed ap­proval for blad­der can­cer

Seagen’s Pad­cev and Mer­ck’s Keytru­da have been cleared by the FDA as a com­bo for first-line treat­ment of blad­der can­cer, po­ten­tial­ly push­ing Pad­cev in­to a multi­bil­lion-dol­lar mar­ket just as Pfiz­er pre­pares to con­sum­mate its $43 bil­lion buy­out of Seagen.

The FDA hand­ed out the ac­cel­er­at­ed ap­proval based on pos­i­tive da­ta from a mul­ti-co­hort study with Pad­cev (en­for­tum­ab ve­dotin) and Keytru­da (pem­brolizum­ab) in pa­tients with lo­cal­ly ad­vanced or metasta­t­ic urothe­lial can­cer who are in­el­i­gi­ble for cis­platin-con­tain­ing chemother­a­py.

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