Hoffmann-La Roche (Roche Canada) has received Health Canada’s approval for Alecensaro (alectinib) to treat patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Alecensaro monotherapy is now approved as adjuvant treatment following tumour resection for patients with stages 1B to 3A of the condition.
The drug is an oral highly selective and potent ALK and Rearranged during Transfection (RET) tyrosine kinase inhibitor.
In April 2024, Alectinib was approved by the US Food and Drug Administration (FDA) for the same indication.
The Canadian approval was based on data from Phase 3 randomised, active-controlled, multicentre, open-label ALINA trial.
The trial assessed the efficacy and safety of adjuvant alectinib compared with platinum-based chemotherapy in people with resected Stage 1B to 3A ALK-positive NSCLC.
It involved 257 patients randomly allocated to receive either alectinib or chemotherapy.
The primary endpoint was disease-free survival (DFS). Secondary measures included overall survival, central nervous system-DFS, and the incidence of adverse events among patients.
As per the results, alectinib significantly decreased the risk of disease recurrence or death by 76% in individuals.
Lung Cancer Canada president Stephanie Snow said: “Surgery alone has not been enough to manage early-stage ALK-positive NSCLC, and the high risk of recurrence for patients has been a serious concern.
“The magnitude of disease-free survival benefit observed in the ALINA study was unprecedented and consistent across all disease stages.
“Now, early ALK testing and treatment with Alecensaro gives patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread.”
After receiving Health Canada’s authorisation, Roche Canada is planning to collaborate with Canada’s health technology assessment agencies along with the pan-Canadian Pharmaceutical Alliance (pCPA), and provincial and territorial governments.
The collaboration aims to ensure timely and equitable access for patients to Alecensaro.
