Roche: FDA grants priority review to Tecentriq combination

(CercleFinance.com) - The US Food and Drug Administration has granted priority review for Roche drug Tecentriq for treating triple-negative breast cancer, an aggressive disease, the Swiss drugmaker said on Tuesday.


The FDA has accepted the company's application and granted priority review for Tecentriq plus chemotherapy for the initial treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose disease expresses the PD-L1 protein.

If approved, the Tecentriq combination would be the first cancer immuno-therapy regimen for the treatment of PD-L1-positive, metastatic triple-negative breast cancer, Roche said.

A priority review designation is granted to medicines that the FDA has determined as having the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

The FDA is expected to make a decision on approval by 12 March 2019.

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