Roche's Inavolisib Breast Cancer Treatment Gets FDA Breakthrough Therapy Designation

By Pierre Bertrand

Roche said that the U.S. Food and Drug Administration has designated its Inavolisib breast cancer treatment as a breakthrough therapy.

A breakthrough therapy designation is given to accelerate the development and regulatory review of medicines intended to treat serious or life-threatening conditions where preliminary data shows the possibility of a substantial improvement over other existing therapies.

The designation follows phase three study results showing that the drug reduced by 57% the risk of death or the disease worsening, Roche said.

The treatment is also being investigates in two other company-sponsored Phase III clinical studies. The data from the study will be submitted to other global health authorities, including the European Medicines Agency, the Swiss drug maker said.

Write to Pierre Bertrand at [e-mail]

(END) Dow Jones Newswires

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