NEWS

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 Garrway 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, 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 ALKspecific 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.”