FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Roche Gains Priority Review for Tecentriq Combo Treatment in Cancer Patients

May 10, 2018
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The FDA granted priority review for Roche’s Tecentriq (atezolizumab) used in combination with Avastin (bevacizumab), paclitaxel and chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) patients.

Roche’s phase III results — which met its co-primary endpoints of overall and progression-free survival — showed the combination therapy could potentially provide a significant survival benefit in the initial treatment of NSCLC. Its safety profile combination was consistent with the profiles for the individual medicines and no new safety signals were identified.

Tecentriq is already approved by the FDA to treat metastatic NSCLC in patients whose condition progresses during or following platinum-containing chemotherapy and who have progressed on an FDA-approved targeted therapy, if their tumor has epidermal growth factor receptor or anaplastic lymphoma kinase mutations.

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