Another Seagen win, with full FDA approval for Pfizer’s Tivdak

On April 29, the US Food and Drug Administration granted traditional approval to Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Developed by Seagen, now a part of US pharma giant Pfizer (NYSE: PFE), and Denmark’s Genmab (OMX: GEN), Tivdak received accelerated approval for this indication in 2021. The drug is now co-owned by Genmab and Pfizer, under an agreement in which the companies share costs and profits for the product on a 50:50 basis.

"Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Dr Chris Boshoff, chief oncology officer, executive vice president at Pfizer. “Today’s full approval by the FDA reinforces the important role of Tivdak for these patients, as the first antibody-drug conjugate with statistically-significant prolonged overall survival data,” he added.