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 and conjunctival adverse reactions were among the most commonly reported safety issues.
Tivdak received accelerated approval from the FDA in September 2021. It was originally developed by Genmab and Seagen; Pfizer acquired Seagen for $43 billion in 2023.
ADCs deliver targeted therapy specifically to cancer cells with the potential to minimize damage to healthy cells. In recent years, drugmakers have put billions toward the advancement of such treatments, which analysts say is likely due to improvements in technology that seem to have made newer iterations of the drugs more safe and effective.