R Roche announced that the European Commission has approved Alecensa®? (alectinib) monotherapy, as adjuvant treatment following tumour resection for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence (Stage IB [4 cm-IIIA NSCLC [7h edition UICC/AJCC). Data from the Phase III ALINA trial, where Alecensa demonstrated an unprecedented 76% reduction in the risk of disease recurrence or death in people with resected ALK-positive NSCLC, supported the marketing authorisation application.

In the ALINA study, Alecensa reduced the risk of disease recurrence and death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, pNew England Journal of Medicine in April 2024. Alecensa is the preferred treatment option for patients with advanced ALK-positiveNSCLC and has transformed outcomes for people with this disease. Approved in more than 100 countries as a first- and second-line treatment, more than 94,000 patients with advanced disease have been treated with Alecensa in clinical practice.

Following its approval in the adjuvant treatment setting, Alecensa could for the first time play a pivotal role in ALK-positive resectable disease, where there is a significant unmet medical need. Today's approval in Europe follows the April 2024U.S. Food and Drug Administration (FDA) approval of Alecensa as adjuvant treatment following tumor resectable disease, as detected by an FDA-approved test. Submissions to additional health authorities worldwide are ongoing to bring this much-needed new treatment option to as many patients as possible.

Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan and China. Alecensa was approved by the U.S. Food and Drug administration (FDA) in April 2024 as adjuvant treatment following cancer resection for patients with ALK- positive NSCLC (tumours 4 cm or node positive), as detected by an FDA- approved test. Submissions to additional Health authorities worldwide are ongoing to bring This much-needed new treatment option.