Roche Breast-Cancer Drug Gets Priority Review in the U.S.

By Adria Calatayud

Roche Holding said the U.S. Food and Drug Administration granted priority review to the company's new drug application for inavolisib as a treatment for a type of advanced breast cancer.

The Swiss pharmaceutical company said Wednesday that the target date for an FDA decision is Nov. 27.

The application for inavolisib--an oral therapy that works in combination with two other drugs--was based on positive results of a late-stage clinical trial, Roche said.

The study, in patients with a type of advanced or metastatic breast cancer, showed a reduction in the risk of disease worsening or death, the company said.

Write to Adria Calatayud at [e-mail]

(END) Dow Jones Newswires

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