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FDA Approves Genentech's Alecensa as Adjuvant Treatment for ALK-Positive Lung Cancer

NEW YORK – The US Food and Drug Administration on Thursday approved Genentech's kinase inhibitor Alecensa (alectinib) as an adjuvant therapy for patients with ALK-positive non-small cell lung cancer as determined by an FDA-approved test.

The agency based its decision on results from the Phase III ALINA trial in which Alecensa reduced the risk of disease recurrence or death by 76 percent compared to platinum-based chemotherapy in patients who had completely resected stage IB to IIIA NSCLC and tested positive for ALK rearrangements. After three years, 89 percent of patients on Alecensa had no disease recurrence, compared with 54 percent of those on chemotherapy. In the trial, investigators also saw an improvement in central nervous system disease-free survival, while safety and tolerability were consistent with previous studies in the metastatic setting.

Alecensa was first approved as a second-line therapy for ALK-positive NSCLC in 2015. It is now the second molecularly targeted treatment approved in the adjuvant NSCLC setting. The FDA approved AstraZeneca's Tagrisso (osimertinib) in 2020 as an adjuvant treatment for EGFR-mutated NSCLC patients based on data showing the EGFR inhibitor improved disease-free survival over chemotherapy.

"At Genentech, our goal is to give patients the best chance of a cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread," Levi Garraway, chief medical officer and head of global product development at Genentech, a Roche subsidiary, said in a statement. "This approval brings us one step closer to achieving that mission."