FDA Grants Full Approval to Pfizer’s Tivdak for Advanced Cervical Cancer Treatment

1. The U.S. Food and Drug Administration (FDA) has granted full approval to Pfizer's Tivdak (tisotumab vedotin-tftv) for the treatment of advanced cervical cancer.
2. Tivdak is an antibody-drug conjugate designed to target and kill cancer cells, while minimizing damage to healthy cells.
3. The FDA's decision follows a positive recommendation from the Oncologic Drugs Advisory Committee (ODAC), which reviewed the clinical data supporting Tivdak's efficacy and safety.
4. Tivdak's approval is based on the results of a phase 2 clinical trial, which demonstrated a significant improvement in overall survival and progression-free survival in patients with advanced cervical cancer.
5. Tivdak is the first FDA-approved treatment for advanced cervical cancer in over a decade, providing a new therapeutic option for patients with limited treatment options.
6. Pfizer plans to launch Tivdak in the U.S. market in the coming weeks, with a list price of $12,000 per month.
7. Tivdak's approval is a significant milestone for Pfizer, as it expands the company's oncology portfolio and strengthens its position in the cervical cancer treatment market.