Saturday, June 22, 2024

Lung Cancer Breakthrough: European Commission Approves Roche’s Alecensa®

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The European Commission has approved Roche’s Alecensa® (alectinib) as the first targeted adjuvant treatment for people with ALK-positive early-stage lung cancer. This marks a significant advancement, addressing the urgent need for effective post-surgery treatments. Alecensa’s approval follows the results of the Phase III ALINA study, which demonstrated a 76% reduction in the risk of disease recurrence or death in patients with resected ALK-positive non-small cell lung cancer (NSCLC). The approval, effective June 10, 2024, offers new hope for those at high risk of recurrence.

The ALINA study showed that Alecensa significantly reduces disease recurrence in early-stage ALK-positive NSCLC. Patients treated with Alecensa after surgical resection experienced a 76% lower risk of recurrence or death compared to those receiving standard platinum-based chemotherapy (HR=0.24, 95% CI: 0.13-0.43, p<0.0001). This finding is crucial as approximately half of early-stage lung cancer patients face recurrence post-surgery despite chemotherapy. Alecensa also showed an improvement in central nervous system disease-free survival (HR=0.22; 95% CI: 0.08-0.58), addressing a common issue in ALK-positive NSCLC patients who are prone to brain metastases.

Alecensa Gains European Approval for Adjuvant Therapy in ALK-Positive Lung Cancer

Alecensa’s approval as an adjuvant therapy transforms the treatment landscape for ALK-positive NSCLC. For the first time, European patients who have undergone surgery for ALK-positive NSCLC can use an ALK inhibitor to significantly reduce recurrence risk. This is particularly important given the high recurrence rates in early-stage lung cancer. According to Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer, this approval is a landmark, offering substantial benefits to patients historically facing high recurrence risks after surgery.

The approval of Alecensa follows its earlier approval by the U.S. FDA in April 2024 for adjuvant use post-tumor resection in ALK-positive NSCLC. This dual approval underscores the drug’s efficacy and the urgent need to provide effective treatments to a broader patient population. International guidelines, including those from the National Comprehensive Cancer Network (NCCN), recommend routine biomarker testing (ALK, EGFR, and PD-L1) in resected surgical tissue or biopsy for stage IB to IIIA NSCLC to identify patients who could benefit from such treatments.

Lung Cancer

Alecensa’s Approval Aims to Reduce Recurrence and Improve Survival Rates

The global lung cancer burden remains substantial, with 1.8 million deaths annually. NSCLC accounts for 85% of lung cancer cases, with a significant portion experiencing recurrence post-surgery. Alecensa’s approval in Europe and the U.S. marks a pivotal step in addressing this unmet medical need. By preventing disease progression and offering early intervention, Alecensa could drastically improve survival rates and quality of life for patients worldwide.

Roche continues to invest in lung cancer research, aiming to develop innovative treatments and diagnostics to combat this deadly disease. The company’s commitment extends beyond treatment, focusing on personalized healthcare to provide the best care tailored to individual patient needs. Roche’s efforts in sustainability and improving healthcare access have been recognized by the Dow Jones Sustainability Indices, reflecting the company’s long-term commitment to health and innovation.

 

Resource: Roche, June 10, 2024

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