Posted by Michael Wonder on 06 Sep 2018
FDA extends review time for Roche’s Tecentriq/Avastin combination
6 September 2018 - US regulators have extended the review period for Roche’s application to market Tecentriq in combination with Avastin, carboplatin and paclitaxel for first-line treatment of metastatic non-squamous non-small cell lung cancer.
The US Food and Drug Administration needs an extra three months to review additional information requested in support of the supplemental Biologics License Application, Roche said.
The combination was granted priority review in May based on results from the Phase III IMpower150 study, but the regulator is now expected to make a decision on approval by December 5.
