publication date: Dec. 7, 2018

Drugs & Targets

FDA approves Tecentriq + Avastin and carboplatin for initial treatment of specific type of metastatic lung cancer

FDA has approved Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

Tecentriq is sponsored by Genentech, a member of the Roche Group.

“This Tecentriq regimen has demonstrated a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer,” said Sandra Horning, chief medical officer and head of Global Product Development. “Today’s approval supports our combination approach for Tecentriq in lung cancer and our vision to develop medicines that improve outcomes for patients with this complex disease.”

The approval is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer compared to Avastin and chemotherapy (median overall survival [OS] = 19.2 versus 14.7 months; hazard ratio [HR] = 0.78; 95 percent CI: 0.64-0.96; p=0.016) in the intention-to-treat wild-type (ITT-WT) population. The safety profile of the Tecentriq combination was consistent with that observed in previous studies.

Genentech is working with FDA on postmarketing commitments to better understand and characterize the potential effects of Tecentriq-related anti-drug antibodies and neutralizing antibodies across all of our studies. An analysis of ADAs in the IMpower150 study showed no impact on the efficacy of Tecentriq.

Tecentriq is also approved by FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK genetic alterations.

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