BioCentury
ARTICLE | Clinical News

FDA extends review of Tecentriq/Avastin combo for NSCLC

September 7, 2018 6:07 PM UTC

Roche (SIX:ROG; OTCQX:RHHBY) said FDA extended review for an sBLA for Tecentriq atezolizumab by three months to Dec. 5. The original PDUFA date was Sept. 5. The sBLA , which FDA is evaluating under Priority Review, is for Tecentriq in combination with Avastin bevacizumab, paclitaxel and carboplatin as first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) (see "Priority Review for Roche's Tecentriq in First-Line NSCLC").

Roche said the extension is to allow FDA time to review additional information requested in support of the sBLA, but did not provide details...

BCIQ Company Profiles

Roche