FX.co ★ European Commission Approves Roche's Alecensa For ALK-positive Early-stage Lung Cancer

Roche (RHHBY) has announced that the European Commission has granted approval for Alecensa (alectinib) as a monotherapy for the adjuvant treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who are at high risk of recurrence following tumor resection.

This approval is backed by the significant findings from the Phase III ALINA trial, where Alecensa showed an astounding 76% reduction in the risk of disease recurrence or death among individuals with resected ALK-positive NSCLC.

The European Commission's decision follows the earlier approval by the U.S. Food and Drug Administration (FDA) in April 2024, which authorized Alecensa for adjuvant treatment for patients with ALK-positive NSCLC, specifically for tumors that are 4 cm or larger or are node-positive, as determined by an FDA-approved test.

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