Approvals

Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) for the adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Alecensa is now the first and only FDA-approved ALK inhibitor approved for patients with ALK-positive early-stage NSCLC who have already undergone surgery to remove the tumour.

The approval follows positive results from the phase 3 ALINA study, which demonstrated that Alecensa reduced the risk of disease recurrence or death by 76% compared to platinum-based chemotherapy in people with completely resected IB to IIIA ALK-positive NSCLC.

Levi Garraway MD PhD, Roche’s chief medical officer and head of global product development, commented: “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. At Roche, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread. This approval brings us one step closer to achieving that mission.”

Ken Culver, director of Research and Clinical Affairs at ALK Positive, Inc, added: “The approval of Alecensa marks a pivotal moment for people newly diagnosed with early-stage ALK-positive lung cancer, who until now, were not able to receive ALK-specific therapy. These patients, who are typically diagnosed at a younger age, often face recurrence and have a higher risk of developing brain metastases than those with other types of NSCLC. Now, with this significant advance, it is more important than ever that all people diagnosed with early-stage lung cancer undergo testing for ALK and other recommended biomarkers to receive the treatment most appropriate for them.”