FDA approves Roche ’s Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer

Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC)1This approval helps address an urgent unmet need, with abouthalf of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy2TheNational Comprehensive Cancer Network ® (NCCN®)Guidelines recommend routine testing for ALK, EGFR and PD-L1 biomarkers in people with early-stage NSCLC to inform adjuvant therapy selectionBasel, 19 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa ® (alectinib) for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours ≥ 4 cm or node positive), as detected by an FDA-approved test. Alecensa is now the first and only ALK inhibitor approved for peop le with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumour.“With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Globa l Product Development. “At Roche, our goal is to give patients the bes...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news