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FDA Delays Decision on Frontline Atezolizumab for NSCLC

Silas Inman @silasinman
Published: Thursday, Sep 06, 2018

The FDA has extended the review period for a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq) for use in combination with bevacizumab (Avastin), carboplatin, and paclitaxel (ABCP) for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC).

UPDATE 12/6/2018: FDA Approves Frontline Atezolizumab Regimen for NSCLC

Roche (Genentech), the manufacturer of the PD-L1 inhibitor atezolizumab, reported in a press release that the extension will allow ample time for the FDA to review additional information it requested for the application. The new action date for the sBLA is December 5, 2018.

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