Health Canada approves new indication for lung cancer treatment option ALUNBRIG®
First-line indication offers Canadians with advanced lung cancer new treatment options
TORONTO, March 17, 2021 /CNW/ - Takeda Canada Inc. is pleased to announce that Health Canada has issued ALUNBRIG® (brigatinib tablets) marketing authorization without conditions as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase positive (ALK+) locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).1 The approval is based on results from the phase 3 ALTA-1L trial which evaluated 275 patients and showed that once-daily ALUNBRIG® was superior to crizotinib on measures of efficacy and tolerability making it a promising first-line treatment option.2
"This is important news for Canadians living with ALK+ locally advanced or metastatic non-small cell lung cancer. New treatment options are essential to support patients on their journey. Having access to clinically evaluated therapies provides choices to stay ahead of cancer," said Dr. Geoffrey Liu, Senior Scientist, Princess Margaret Cancer Care Centre, University Health Network. "This new indication will be crucial to improving the health of Canadians impacted by ALK+ locally advanced or metastatic NSCLC. I look forward to sharing this positive announcement with patients."
Non-small cell lung cancer is the most common form of lung cancer, accounting for approximately 80 to 85 per cent of lung cancers diagnosed in Canada each year.3 There are many different subtypes of NSCLC that start in the different types of cells and tissues of the lung. ALK+ is a subset of NSCLC, often striking people at a younger age, many of whom have never smoked.4 Studies indicate that chromosomal rearrangements in the ALK gene is a key driver in this subset of NSCLC patients. Between three to five per cent of patients diagnosed with locally advanced or metastatic NSCLC test positive for the ALK gene rearrangement.5
"The approval of ALUNBRIG® is a significant step forward for Canadians battling advanced forms of lung cancer, who now have a new treatment option available in their fight against a devastating disease," says David Fyshe, Oncology Country Head, Takeda Canada. "We are proud of ALUNBRIG® clinical results demonstrating first-line treatment benefits. This new oncology indication directly supports Takeda's on-going commitments to uncover solutions for people living with cancer."
In 2018, ALUNBRIG® (brigatinib) was issued marketing authorization with conditions, pending the results of trials, as a monotherapy for the treatment of adult patients with ALK+ metastatic NSCLC who have progressed on or who were intolerant to an ALK inhibitor (crizotinib).
About the Phase 3 ALTA 1L Trial
The safety and efficacy of brigatinib was evaluated in a, Phase 3 open-label, multicenter trial (ALTA 1L) in 275 adult patients with advanced ALK+ NSCLC who had not previously received an ALK-targeted therapy with a documented ALK rearrangement based on a validated ALK testing. Patients could have up to 1 prior regimen of systemic anticancer therapy in the locally advanced or metastatic setting and had an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. The major efficacy outcome measure was progression-free survival as evaluated by a Blinded Independent Review Committee (BIRC).
About ALUNBRIG® (brigatinib)
ALUNBRIG® is a targeted medicine that blocks the action of the altered ALK gene to help shrink or slow cancer growth. ALUNBRIG® is administered orally, beginning with seven days of 90 mg once daily, followed by 180 mg once daily thereafter. ALUNBRIG® is now indicated as a monotherapy for the first-line treatment of adult patients with ALK+ locally advanced (not amenable to curative therapy) or metastatic NSCLC and as a monotherapy for the treatment of adult patients with ALK+ metastatic NSCLC who have progressed on or who were intolerant to an ALK inhibitor (crizotinib).1
ALUNBRIG® and the ALUNBRIG Logo® are registered trademarks of ARIAD Pharmaceuticals, Inc.
About Takeda Canada Inc.
Takeda Canada Inc. is the Canadian marketing and sales organization of Takeda Pharmaceutical Company Limited, headquartered in Japan. Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
Additional information about Takeda Canada is available at www.takeda.com/en-ca.
1 ALUNBRIG® Product Monograph. Date of Revision March 2, 2021. Available at https://www.takeda.com/4a4cc3/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/alunbrig/alunbrig-pm-en.pdf. Accessed March 2021.
2 Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, García Campelo MR, Kim DW, Griesinger F, Felip E, Califano R, Spira A, Gettinger SN, Tiseo M, Lin HM, Gupta N, Hanley MJ, Ni Q, Zhang P, Popat S. Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial. J Clin Oncol. 2020 Nov 1;38(31):3592-3603. doi: 10.1200/JCO.20.00505. Epub 2020 Aug 11. PMID: 32780660; PMCID: PMC7605398. Accessed March 2021.
3 Canadian Cancer Society. Malignant tumours of the lung. Available at http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/cancerous-tumours/?region=on. Accessed February 2021.
4 Gridelli, et al. ALK inhibitors in the treatment of advanced NSCLC. Cancer Treat Rev 2014;40(2): 300–306.
5 Gainor JF, Varghese AM, Ou SH, et al. ALK rearrangements are mutually exclusive with mutations in EGFR or KRAS: an analysis of 1,683 patients with non-small cell lung cancer. Clin Cancer Res. 2013; 19(15):4273-81.
SOURCE Takeda Canada Inc