On Monday, the U.S. Food and Drug Administration (FDA) announced the full approval of Pfizer’s medication for treating individuals with cervical cancer, whose disease has advanced during or after chemotherapy.
In 2021, the FDA granted rapid approval for Tivdak, an antibody-drug conjugate therapy co-developed by Genmab A/S and Seagen. Additionally, it was approved for the same indication.
It was included in Pfizer’s oncology portfolio last year when Seagen and other targeted cancer medications were purchased for $43 billion.
The data from a late-stage experiment with 502 individuals enrolled served as the foundation for the health regulator’s complete clearance. It compared the decision of treatment made by investigators for patients with cervical cancer with Tivdak.
In comparison to chemotherapy, Tivdak showed a 30% lower risk of patient death in the experiment.
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