(Reuters) -The U.S. Food and Drug Administration (FDA) granted full approval for Pfizer’s drug for treating cervical cancer patients whose disease had progressed on or after chemotherapy, the agency said on Monday.
The treatment, Tivdak – an antibody-drug conjugate co-developed by Genmab A/S and Seagen – received the FDA’s accelerated approval for the same indication in 2021.
It was added to Pfizer’s oncology portfolio last year through a $43 billion deal to acquire Seagen, along with other targeted cancer therapies.
The health regulator’s full approval was based on data from a late-stage trial that enrolled 502 patients. It tested Tivdak versus investigators’ choice of chemotherapy in patients with cervical cancer.
Tivdak in the trial demonstrated a 30% reduction in the risk of death in patients, compared with chemotherapy.
(Reporting by Pratik Jain in Bengaluru; Editing by Anil D’Silva)
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