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European Commission Grants Approval for Roche's Alecensa as the Premier Targeted Adjuvant Therapy for Early-Stage Lung Cancer with ALK Mutation

Monday, June 10, 2024

Roche has received approval from the European Commission for Alecensa® (alectinib) as an adjuvant treatment following surgery for adult patients with ALK-positive non-small cell lung cancer (NSCLC) who are at high risk of recurrence (Stage IB [≥4 cm]–IIIA NSCLC [7th edition UICC/AJCC]). This approval is supported by findings from the Phase III ALINA trial, which demonstrated that Alecensa significantly reduces the risk of disease recurrence or death by 76% in patients who have had their tumors surgically removed.

Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development, noted that this approval provides a new treatment option for patients who have had surgery for ALK-positive NSCLC, potentially reducing the likelihood of cancer returning.

Professor Fabrice Barlesi, a thoracic oncologist, stressed the importance of early ALK testing to identify patients who could benefit from this therapy, given the significant disease-free survival benefits observed in the ALINA study.

Alecensa has already revolutionized treatment for advanced ALK-positive NSCLC and is approved in more than 100 countries for both first- and second-line treatments. This new indication in the adjuvant setting addresses a notable unmet need in treating ALK-positive resectable disease. Following its approval in the U.S. by the FDA as an adjuvant treatment, applications to other health authorities are currently in progress.

The ALINA study, a Phase III, randomized, active-controlled trial, assessed Alecensa's efficacy and safety in patients with resected Stage IB to IIIA ALK-positive NSCLC. The primary focus of the study was disease-free survival, with secondary outcomes including overall survival and the occurrence of adverse events.

Lung cancer remains a leading cause of cancer-related deaths worldwide, with NSCLC being the predominant type. Effective early treatment is critical to prevent recurrence and provide the best chance for a cure.

Alecensa, a selective oral medication with central nervous system activity, has been approved in over 100 countries for treating metastatic ALK-positive NSCLC. Roche continues to invest in developing new treatments and diagnostic tests for lung cancer, aiming to offer effective therapies to all patients diagnosed with this disease.



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