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 adria.calatayud@wsj.com
(END) Dow Jones Newswires
05-29-24 0131ET