BeOne Medicines Receives US FDA Priority Review for Tevimbra Combination Therapy

MT Newswires Live04-29

BeOne Medicines' (ONC) supplemental biologics license application for Tevimbra, in combination with Ziihera and chemotherapy, was granted priority review designation by the US Food and Drug Administration, the company said Wednesday.

This drug is for patients with a specific type of stomach or throat cancer that has spread or cannot be removed by surgery. It specifically targets tumors that test positive for a protein called HER2, which helps the cancer grow.

Interim data from a phase 3 trial of the combination therapy supported the application, with the Tevimbra combination demonstrating statistically significant improvement in overall survival and progression-free survival, the company said.

The combination therapy's safety findings in the trial were generally consistent with the component's known effects, BeOne Medicines added.

Price: 296.42, Change: -1.74, Percent Change: -0.58

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