Biotech Stocks Facing FDA Decision In September


Roche’s (RHHBY.OB) supplemental Biologics License Application seeking approval for Tecentriq in combination with Avastin, paclitaxel and carboplatin for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer awaits the FDA decision on September 5.

Tecentriq is currently approved by the FDA to treat people with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has ALK and EGFR mutations. The drug is also approved to treat the most common type of bladder cancer, called urothelial carcinoma.

In the first half of 2018, Tecentriq generated sales of CHF320 million, up 37% over the comparable year-ago period.

RHHBY.OB closed Thursday’s trading at $31.13, down 0.19%.