Roche gets European approval for Tecentriq in combo with Avastin, chemotherapy

ZURICH: Roche has received European Commission approval for its Tecentriq drug in combination with Avastin and chemotherapy as an initial treatment for people with a specific type of lung cancer, the Swiss pharma company said on Friday.

Medical Dialogues had earlier reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended the approval of Tecentriq (atezolizumab), in combination with Avastin(bevacizumab), paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC).

Based on the positive CHMP recommendation, a final decision regarding the approval of this Tecentriq-based combination was expected from the European Commission in the near future.

The CHMP recommendation was based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin, paclitaxel and carboplatin helped people live significantly longer, compared with Avastin and chemotherapy (median overall survival [OS]=19.8 versus 14.9 months; hazard ratio [HR]=0.76; 95%, CI: 0.63–0.93; p=0.006) in the intention-to-treat (ITT) population.

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The combination has been approved as a first-line treatment for people with metastatic non-squamous non-small cell lung cancer (NSCLC).