Pfizer, Genmab cervical cancer therapy wins full FDA approval [Seeking Alpha]
Genmab A/S - American Depositary Shares (GMAB)
Company Research
Source: Seeking Alpha
FDA accepted a supplemental Biologics License Application granting full approval for their cervical cancer therapy, Tivdak (tisotumab vedotin-tftv). Tivdak becomes the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer. The drug previously received FDA's accelerated approval in September 2021 for adults with cervical cancer who have previously undergone chemotherapy. The full approval is based on positive results from a global Phase 3 study, demonstrating overall survival benefit of Tivdak compared to chemotherapy in adult patients with previously treated recurrent or metastatic cervical cancer. The innovaTV 301 study showed a 30% reduction in the risk of death compared to chemotherapy, with median overall survival for Tivdak-treated patients being 11.5 months. The study was conducted by Seagen, which was acquired by Pfizer ( PFE ) in December 2023, in collaboration with Genmab
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