FDA Approves Genentech's Alecensa For ALK-positive Early-Stage Lung Cancer

(RTTNews) - Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration has approved Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer or NSCLC (tumors 4 cm or node positive), as detected by an FDA-approved test.

The company noted that Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor.

The approval is based on positive results from the Phase III ALINA study that demonstrated Alecensa reduced the risk of disease recurrence or death by 76% compared with platinum-based chemotherapy in people with completely resected IB (tumor 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.

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