The approval was based on results from Phase 3 ALINA study in which Alecensa lowered the risk of disease recurrence or death by 76% in comparison to chemotherapy
FDA clears Roche’s Alecensa as the first adjuvant treatment of ALK-positive NSCLC. (Credit: F. Hoffmann-La Roche Ltd.)
Roche has received the US Food and Drug Administration (FDA) approval for Alecensa (alectinib) for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Alecensa is a highly selective, central nervous system (CNS)-active, oral medicine. It was approved as first- and second-line treatment for ALK-positive metastatic NSCLC.
The drug has been now cleared as adjuvant treatment post-tumour resection for NSCLC patients, as identified by an FDA-approved test.
The FDA’s approval was based on promising outcomes from the Phase 3 ALINA study which assessed the efficacy and safety of alectinib against platinum-based chemotherapy.
The randomised, active-controlled, multicentre, open-label trial evaluated people with resected Stage IB to 3A ALK-positive NSCLC.
It included 257 patients who were randomised to receive alectinib 600mg orally twice daily or platinum-based chemotherapy following tumour resection.
The primary endpoint was defined as disease-free survival (DFS) and secondary endpoints included overall survival, CNS-DFS, and the percentage of patients experiencing adverse events.
According to the results, Alecensa lowered the risk of disease recurrence or death by 76% in comparison to chemotherapy.
The exploratory analysis revealed an enhancement in CNS disease-free survival.
The safety profile of the drug in this late-stage trial remained largely in line with prior studies in the metastatic setting, with no unforeseen safety issues reported.
Roche chief medical officer and global product development head Levi Garraway said: “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.”
The FDA’s review of this application was conducted within the framework of the Project Orbis initiative, facilitating simultaneous submission and review of oncology drugs among international collaborators.
The American health agency partnered with agencies in Australia, Canada, Israel, Switzerland, and the UK.
ALINA study’s results will be used for filing submissions to additional global health authorities, including the European Medicines Agency.