Roche has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]), for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR mutant or ALK-positive NSCLC.
This decision is based on results from the Phase III IMpower130 study, which demonstrated that the Tecentriq combination therapy helped people live significantly longer, compared with chemotherapy alone (median overall survival [OS]=18.6 versus 13.9 months; hazard ratio [HR]=0.79; 95% CI: 0.64–0.98; p=0.033) in the intention-to-treat (ITT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with chemotherapy alone (median PFS=7.0 versus 5.5 months; HR=0.64; 95% CI: 0.54–0.77; p<0.0001) in the ITT-WT population. The safety profile of the Tecentriq combination therapy was consistent with that observed in previous studies.
“We are pleased to receive a positive opinion from the CHMP for this Tecentriq-based lung cancer combination for people living with non-squamous non-small cell lung cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Lung cancer is a complex disease that requires a range of treatment options. We are now one step closer to providing another important alternative for this difficult-to-treat form of cancer”.
Despite recent advances in the treatment of NSCLC, there is still a need for new options to support a tailored approach to treatment of this complex disease. Lung cancer is the leading cause of cancer death globally. Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.
Based on the CHMP positive opinion, a final decision regarding the approval of this Tecentriq-based combination is expected from the European Commission in the near future.
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