FDA converts Pfizer’s Tivdak to full approval in cervical cancer

Pfiz­er’s new cer­vi­cal can­cer drug Tiv­dak has been con­vert­ed from an ac­cel­er­at­ed to a full ap­proval.

The Seagen and Gen­mab-parterned drug, al­so known as ti­so­tum­ab ve­dotin-tftv, was first ap­proved via the FDA’s ac­cel­er­at­ed path­way in Sep­tem­ber 2021. It’s now in Pfiz­er’s port­fo­lio, fol­low­ing the New York phar­ma gi­ant’s $43 bil­lion ac­qui­si­tion of Seagen at the end of last year.

The full ap­proval was based on an open-la­bel study show­ing that Tiv­dak pa­tients saw a me­di­an over­all sur­vival of 11.5 months com­pared to 9.5 months for pa­tients who re­ceived on­ly chemother­a­py (p=0.0038). Me­di­an pro­gres­sion-free sur­vival in the Tiv­dak arm was 4.2 months, com­pared to 2 months in the chemother­a­py arm. Tiv­dak gen­er­at­ed $64 mil­lion in sales for Seagen over the first nine months of 2023, be­fore the com­pa­ny was ac­quired by Pfiz­er.

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