Roche wins speedy FDA review for Tecentriq; South Korean authorities to look into Samsung BioLogics accounting practices
→ Trailing behind immunotherapy offerings from Merck $MRK and Bristol-Myers Squibb $BMY, Roche $RHHBY has been plotting to secure approval of its Tecentriq for difficult-to-treat cancers. On Tuesday, the Swiss drugmaker announced the FDA had agreed to an accelerated review of Tecentriq in combination with the chemotherapy Abraxane for initial treatment of metastatic triple-negative breast cancer with tumors that test positive for the protein PD-L1. The priority review designation means the FDA is expected to make a decision on the drug by March 12, 2019, Roche said.
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