Pfizer and Genmab's Tivdak wins full FDA approval for cervical cancer [Yahoo! Finance]
Pfizer, Inc. (PFE)
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Source: Yahoo! Finance
recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The full approval is based on positive data from the Phase III innovaTV 301 clinical trial (NCT04697628). Tivdak significantly improved overall survival, showing a 30% reduction in the risk of death compared to treatment with chemotherapy. Results showed a statistically significant overall survival (OS) rate, with a median OS of 11.5 months for patients treated with Tivdak compared to 9.5 months on chemotherapy alone. Pfizer inherited Tivdak when it acquired Seagen in a $43bn deal in December 2023. Tivdak, a tissue-factor targeting antibody-drug conjugate (ADC) developed in collaboration with Genmab, gained accelerated approval in 2021. In February 2021, Genmab and Seagen submitted a biologics licence application (BLA) for Tivdak seeking accelerated approval from the FDA. The BLA was accepted with priority review in April 2021 and approved in September 2021. The FDA's accelerated approva
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PFE
Earnings
- 5/1/24 - Beat
PFE
Sec Filings
- 5/16/24 - Form 4
- 5/16/24 - Form 4
- 5/9/24 - Form S-8
- PFE's page on the SEC website