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Friday, February 1, 2019

Roche: CHMP recommends EU approval of Tecentriq in combination with Avastin

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Tecentriq, in combination with Avastin, paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer. In people with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies. Based on the positive CHMP recommendation, a final decision regarding the approval of this Tecentriq-based combination is expected from the European Commission in the near future. The CHMP recommendation is 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 in the intention-to-treat population. The safety profile of the Tecentriq combination was consistent with that observed in previous studies.

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