Roche’s anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) has been approved by the US Food and Drug Administration (FDA) to treat a subset of early-stage lung cancer patients.
The drug has specifically been authorised for use as an adjuvant treatment following tumour resection for patients with ALK-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
The regulator’s decision was supported by positive results from the late-stage ALINA study, in which Alecensa was shown to reduce the risk of disease recurrence by 76% compared with platinum-based chemotherapy in this patient population.
An improvement in central nervous system disease-free survival was also observed in those receiving Alecensa, according to an exploratory analysis, and the safety and tolerability of the therapy were generally consistent with previous trials in the metastatic setting.
“Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
Garraway added that the approval brings the company “one step closer” to achieving its goal of giving patients “the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread”.
Lung cancer is one of the leading causes of cancer death globally and NSCLC represents up to 85% of all lung cancer diagnoses.
Approximately half of all patients with early lung cancer experience a cancer recurrence following surgery, despite adjuvant chemotherapy.
Alecensa, created at Chugai, a member of the Roche Group, is already approved in over 100 countries, including the US, as a first- and second-line treatment for ALK-positive, metastatic NSCLC.
Commenting on the latest authorisation for the drug, Ken Culver, director of research and clinical affairs at ALK Positive, said: “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.”
Culver added: “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.”