Hoffmann-La Roche Limited (Roche Canada) announced that on June 27, 2024, Health Canada granted approval of Alecensaro (alectinib) monotherapy as adjuvant treatment following tumour resection for patients with stage IB (tumours 4 cm) to IIIA anaplastic lymphoma kinase (ALK) -positive non-small cell lung cancer (NSCLC). With a 76% reduction in the risk of recurrent disease or death compared to chemotherapy alone, Alecensaro is the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumour. Data from the Phase III ALINA trial supported the Health Canada application and approval, which obtained Priority Review status by Health Canada.

Priority review status applies to a New Drug Submission (NDS) or Supplement New Drug Submission (S/NDS) for a serious, life-threatening or severely debilitating disease or condition for which there is substantial evidence of clinical effectiveness that the drug provides: effective treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in Canada; or a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada. Given that early data signals were positive, the Health Canada application was also conducted under the Project Orbis initiative, a framework for the concurrent submission and review of oncology medicines among international partners. Health Canada collaborated with the Australian Therapeutics Goods Administration (TGA), Singapore'sHealth Sciences Authority, Brazil'sNational Health Surveillance Agency (ANVISA), the US Food & Drug Administration (FDA), Israel'sMinistry of Health (IMoH) Pharmaceutical Administration, Switzerland'sSwissmedic, and the United Kingdom'sMedicines and Healthcare Products Regulatory Agency (UK MHRA).

Now that Health Canada authorization has been secured, Roche Canada looks forward to working with Canada's health technology assessment agencies - Canada's Drug Agency (CDA) and l'Institut national d'ex excellence en santeet en services sociaux (INESSS) - the pan-Canadian Pharmaceutical Alliance (pCPA), as well as provincial and territory governments, to quickly secure sustainable, equitable access for patients to Alecensaro. Lung cancer is one of the leading causes of cancer death globally and, here in Canada, about 1 in 15 women will develop lung cancer in their lifetime and 1 in 14 men will develop the disease. Non-small cell lung cancer is the most common type of lung cancer.

Patients with ALK+ NSCLC are typically younger, often economically active with dependents, and frequently never smokers. This cancer has high recurrence rates and a significant risk of brain metastases, necessitating early and aggressive treatment to prevent disease recurrence and provide the best opportunity for a cure.