Roche today announced that the US Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.
“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, MD, Roche’s 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.”
This 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%, 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.
Roche is working with the FDA on post-marketing commitments (PMCs) to better understand and characterise the potential effects of Tecentriq-related anti-drug antibodies (ADAs) and neutralising antibodies (NAbs) 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 the 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 tumour has EGFR or ALK genetic alterations.
For more information visit : https://www.roche.com/media/releases/med-cor-2018-12-07.htm