FDA Approves Alectinib as First Adjuvant Treatment for ALK-Positive Early-Stage Lung Cancer

The US Food and Drug Administration (FDA) has approved alectinib (Alecensa) as an adjuvant treatment after tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) tumors that are at least 4 cm or node positive, as detected by an FDA-approved test.

Alectinib is a kinase inhibitor that was previously approved as first- and second-line treatment for ALK-positive metastatic NSCLC. It 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,” according to a news release from Genentech, the manufacturer of the drug.

The approval is based on results from the phase 3 ALINA study, which demonstrated that alectinib reduced the risk of disease recurrence or death by 76% compared with platinum-based chemotherapy in people with a completely resected stage IB tumor of at least 4 cm to IIIA ALK-positive NSCLC.

“The safety and tolerability of Alecensa in this trial were generally consistent with previous trials in the metastatic setting, and no unexpected safety findings were observed,” Genentech officials said in the news release.

Source: BusinessWire