Roche announced that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours = 4 cm or node positive), as detected by an FDA-approved test. Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumour. The approval is based on positive results from the Phase III ALINA study that demonstrated Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.001) compared with platinum-based chemotherapy in people with completely resected IB (tumour = 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.1 In an exploratory analysis, an improvement of central nervous system (CNS) disease-free survival was observed (HR=0.22; 95% CI: 0.08-0.58).1 The safety and tolerability of Alecensa in this trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed.1 These data were presented as a late-breaking oral at the European Society of Medical Oncology Congress 2023 Presidential Symposium in October 2023 and were also recently published in the New England Journal of Medicine in April 2024.

Alecensa is a kinase inhibitor currently approved as first- and second-line treatment for ALK-positive metastatic NSCLC. It has demonstrated significant efficacy in patients, including those with CNS metastases, and now with this approval, these benefits could extend to people with early-stage disease. Routine testing of resected surgical tissue or biopsy for ALK, EGFR and PD-L1 biomarkers in patients with stage IB to IIIA and select IIIB (UICC/AJCC 8th edition) NSCLC, in addition to in the advanced setting, is recommended by international guidelines, including the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®), to support clinicians?

decision-making. About 5% of people with NSCLC are ALK-positive, equating to approximately 90,000 people worldwide diagnosed each year. The review of this application was conducted under the FDA?s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners.

According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions. For this review, FDA collaborated with the Australian Therapeutics Goods Administration (TGA), Health Canada (HC), Israel?s Ministry of Health (IMoH) Pharmaceutical Administration, Switzerland?s Swissmedic, and the United Kingdom?s Medicines and Healthcare Products Regulatory Agency (UK MHRA). Brazil'sNational Health Surveillance Agency (ANVISA) and Singapore?s Health Sciences Authority (HSA) will also be participating as Type C Project Orbis Partners.

Additionally, the FDA reviewed and approved the supplemental application under its Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Data from the Phase III ALINA study will also be used for filing submissions to additional global health authorities, including the European Medicines Agency.