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Roche's Tecentriq Gets 2 EU Approvals To Treat Adults With NSCLC, ES-SCLC

Swiss drug major Roche Group (RHHBY) announced Friday two approvals from European Commission for Tecentriq (atezolizumab) to treat adults with non-squamous non-small cell lung cancer or NSCLC, the most common form of advanced lung cancer, and extensive-stage small cell lung cancer or ES-SCLC, respectively.

In a statement, the company announced that the European Commission or EU has approved and granted marketing authorisation for Tecentriq in combination with chemotherapy (carboplatin and Abraxane), for the initial treatment of adults with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK-positive NSCLC.

This approval 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 in the intention-to-treat wild-type or ITT-WT population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared with chemotherapy alone.

Separately, EU approved Tecentriq in combination with chemotherapy for the initial treatment of people with extensive-stage small cell lung cancer or ES-SCLC. Roche noted that this combination is the first and only cancer immunotherapy approved by the European Medicines Agency for the initial treatment of ES-SCLC. The combination significantly improved overall survival and progression-free survival for the first time in over 20 years.

This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone in the intention-to-treat or ITT population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared with chemotherapy alone.

At present, Roche has nine Phase III lung cancer studies underway evaluating Tecentriq alone or in combination with other medicines across different types of lung cancer.

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