SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug major Roche (RHHBY) announced Wednesday that the European Commission has approved Tecentriq (atezolizumab) for people with specific type of lung cancer.
Tecentriq has been approved as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer or NSCLC whose tumours have high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.
Roche noted that Tecentriq is now the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks. This gives physicians and patients greater flexibility on how they manage their treatment.
The latest approval is based on data from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival by 7.1 months compared with chemotherapy in people with high PD-L1 expression (TC3 or IC3-wild-type).
Roche said the approval marks Tecentriq's fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall in the EU.
Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said, 'Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, when compared to chemotherapy, and therefore represents a new treatment option for people living with this difficult-to-treat disease.'
Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets around the world.
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