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.
Tivdak was originally approved with a boxed warning for ocular toxicity, including changes in vision, severe vision loss and corneal ulceration. It’s indicated for second-line patients who’ve progressed on or after chemotherapy treatment.