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Biotech Stocks Facing FDA Decision In March

Roche
Roche

Roche’s (RHHBY.OB) supplemental Biologics License Application seeking approval for Tecentriq in combination with Abraxane for the first-line treatment of people with PD-L1-positive, metastatic triple-negative breast cancer awaits the FDA decision on March 12, 2019.

Tecentriq in combination with carboplatin and etoposide (chemotherapy), for the first-line treatment of people with extensive-stage small cell lung cancer, is also under FDA review, with a decision expected by March 18, 2019.

Tecentriq is currently approved for the treatment of patients with advanced urothelial carcinoma and patients with metastatic non-small cell lung cancer (NSCLC) in the European Union, the United States, and more than 85 countries.

The drug generated annual sales of 772 million Swiss francs in 2018, up 59% over the prior year.

RHHBY.OB closed Tuesday’s trading at $34.81, up 0.59%.