Pfizer’s sBLA for Tivdak Receives the US FDA’s Acceptance for Priority Review to Treat Cervical Cancer
Shots:
- The sBLA was submitted based on the results from the P-III (innovaTV 301) trial evaluating the safety & efficacy of Tivdak vs CT (topotecan/vinorelbine/gemcitabine/irinotecan/pemetrexed) in patients (n=502) with recurrent or metastatic cervical cancer. The assigned PDUFA date is May 09, 2024
- The results from the trial depicted a significantly prolonged OS (30% reduction in risk of death), improved PFS (33% reduction in risk of death), improved ORR vs CT & a DCR rate of 75.9% vs 58.2%
- The sBLA was submitted to convert the accelerated approval, granted based on P-II (innovaTV 204) trial results, to receive full approval. Tivdak is an ADC developed through Genmab’s human mAb directed to TF & Seagen’s ADC technology
Ref: Pfizer | Image: Pfizer
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
