Roche Announces FDA Approval For Alecensa

(RTTNews) - Roche (RHHBY) announced the FDA has approved Alecensa for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer. The company said 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 tumour.

The approval was based on positive results from the Phase III ALINA study. The company noted that the data from the Phase III ALINA study will also be used for filing submissions to additional global health authorities, including the European Medicines Agency.

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