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Seattle Genetics, Astellas get US FDA's priority review for bladder cancer drug

Astellas Pharma Inc. and Seattle Genetics Inc. said their medicine enfortumab vedotin will be reviewed in the U.S. as a bladder cancer treatment on an expedited basis.

The U.S. Food and Drug Administration accepted the companies' biologics license application for the investigational drug and granted it priority review, signifying it will accelerate the approval process. The regulator is expected to make a decision on the application by March 15, 2020.

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The drug has already received the FDA's breakthrough-therapy designation.

The medicine is meant for patients with urothelial cancer whose disease progressed locally or has spread to other parts of the body despite receiving treatment in the past, including immunotherapies and chemotherapy.

Bothell, Wash.-based Seattle Genetics and Japanese drugmaker Astellas said their filing was based on the medicine's effects on the first group of patients that received it in a phase 2 trial dubbed EV-201.

In June 2018, the companies reported results from a phase 1 trial, called EV-101, which showed that enfortumab vedotin helped reduce tumor size in patients with the particular type of bladder cancer.