FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

European Commission Approves Roche’s Tecentriq-Avastin Combo Therapy

March 15, 2019
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The European Commission has approved Roche’s Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy for treating metastatic non-squamous non-small cell lung cancer (NSCLC).

The approval applies to first-line treatment of adult patients with metastatic NSCLC. For patients with EGFR mutant or ALK-positive NSCLC, the combo therapy is only indicated if appropriate targeted therapies have failed.

The commission’s green light was based on data from Roche’s Phase 3 study, which showed the combo therapy helped patients live significantly longer when compared with just Avastin and chemotherapy, the company said.

The FDA approved the Tecentriq-Avastin combo for treating NSCLC in December 2018. The agency had already cleared Tecentriq for treating metastatic NSCLC patients who have disease progression during or after platinum chemotherapy.

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