Roche’s Genentech said that Alecensa scored a label expansion from the FDA, with the drug now approved as an adjuvant treatment following tumor resection in patients with ALK-positive non-small cell lung cancer.
The approval is based on data from the Phase 3 ALINA study that showed Alecensa reduced the risk of disease recurrence or death by 76% compared to those in the control arm who received chemotherapy following surgery.
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