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European Commission Approves Alecensa as Adjuvant Treatment for ALK-Positive Lung Cancer

NEW YORK – Roche on Monday said the European Commission approved Genentech's kinase inhibitor Alecensa (alectinib) as an adjuvant therapy for ALK-positive, early-stage non-small cell lung cancer.

The commission based its decision on results from the Phase III ALINA trial, which demonstrated that Alecensa reduced the risk of disease recurrence or death by 76 percent compared to platinum-based chemotherapy in patients with stage IB to IIIA ALK-positive NSCLC following surgical resection. After three years, 89 percent of patients on Alecensa had no disease recurrence compared with 54 percent of those on chemotherapy. Patients also had improvements in central nervous system disease-free survival.

The US Food and Drug Administration also recently approved Alecensa in the adjuvant early ALK-positive lung cancer setting. It is the first approved targeted therapy in this setting and only the second targeted treatment approved in adjuvant NSCLC following AstraZeneca's Tagrisso (osimertinib), which was approved as an adjuvant treatment in the US for EGFR-mutated NSCLC in 2020

Roche said that about half of patients with early-stage lung cancer experience disease recurrence following surgery despite adjuvant chemotherapy, and the approval of Alecensa will address that unmet need. Fabrice Barlesi, a thoracic oncologist at the Gustave Roussy Institute, said in a statement, "The use of early ALK testing will help to identify all patients that could benefit from this important treatment option."