Becker's Healthcare April 30, 2024
The FDA has granted full approval for Pfizer’s Tivdak (tisotumab vedotin-tftv) to treat cervical cancer in patients whose disease has progressed on or after chemotherapy.
The treatment is the first antibody-drug conjugate, or ADC, that has demonstrated statistically significant survival data. The FDA fully approved the treatment April 29 based on phase 3 trial results that showed an overall survival benefit in adult patients, compared to chemotherapy.
Patients treated with the drug had a 30% lower risk of death compared to chemotherapy, according to the trial results. Decreased hemoglobin levels, peripheral neuropathy...