Osaka - Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) today announced that it has obtained approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market 'ALUNBRIG Tablets 30 mg, 90 mg' (brigatinib, development code: AP26113) as a first and second-line therapy for the treatment of patients with unresectable, advanced or recurrent ALK fusion gene-positive non-small cell lung cancer (ALK+ NSCLC).
The approval is mainly based on the results of Brigatinib-2001 (J-ALTA), a Phase 2 clinical trial conducted in Japan involving 72 ALK+ patients with unresectable advanced or recurrent NSCLC who progressed after treatment with an ALK tyrosine kinase inhibitor, as well as the AP26113-13-301 (ALTA-1L) global Phase 3 clinical trial focused on ALK+ patients with unresectable advanced or recurrent NSCLC who had not been treated with an ALK tyrosine kinase inhibitor.
'While there have been significant advances in diagnosis, testing and treatment of ALK+ NSCLC, effective treatment with ALK inhibitors can still be a challenge given the unique needs of these patients,' said Makoto Nishio, MD, PhD, Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, the principal investigator in the J-ALTA clinical trial. 'ALUNBRIG has been shown to be an effective inhibitor of ALK gene mutations, including in patients with brain metastases, and its approval in Japan is an important milestone for both newly diagnosed and refractory ALK-positive patients.'
Christopher Arendt, Head of the Oncology Therapeutic Area Unit at Takeda added, 'As a next-generation ALK inhibitor, ALUNBRIG is backed by extensive clinical evidence, and has been shown to be effective in patients undergoing first and second-line treatment for ALK+ NSCLC including efficacy in patients with brain metastases. With this approval in Japan, we believe that even more patients will be able to benefit from this targeted therapy in NSCLC caused by ALK driver mutations.'
The most common adverse reactions (25%) reported in Japanese patients treated with ALUNBRIG were increased CPK, diarrhea, hypertension, nausea, increased lipase, increased amylase, increased AST and stomatitis.
About ALK-positive Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 1.8 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization. Genetic studies indicate that chromosomal rearrangements in anaplastic lymphoma kinase (ALK) are key drivers in a subset of NSCLC patients. Approximately 3-5% of patients with metastatic NSCLC have a rearrangement in the ALK gene. Takeda is committed to continuing research and development in NSCLC to improve the lives of the approximately 40,000 patients diagnosed with this serious and rare form of lung cancer worldwide each year.
About ALUNBRIG (brigatinib)
ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) that was designed to target anaplastic lymphoma kinase (ALK) molecular alterations.
ALUNBRIG is approved in more than 30 countries including the U.S. and European Union (EU) as a monotherapy for the treatment of adult patients with ALK+ advanced NSCLC previously not treated with an ALK inhibitor. ALUNBRIG is also approved in more than 50 countries for the treatment of people living with ALK+ metastatic NSCLC who have taken the medicine crizotinib, but their NSCLC has worsened or they cannot tolerate taking crizotinib.
Companion Diagnostic Agents
ALUNBRIG should be administered to patients who have been determined to be ALK+. Abbott Japan's Vysis ALK Break Apart FISH Probe Kit has been approved as a companion diagnostic to assist in the determination of indications for use of ALUNBRIG. Other in vitro diagnostic products and medical devices are also under review.
The Brigatinib-2001 (J-ALTA) Clinical Trial
The purpose of this single-arm, multicenter Phase 2 clinical trial is to evaluate the efficacy and safety of ALUNBRIG in Japanese patients with ALK fusion gene-positive NSCLC. It consists of multiple cohorts, including the main cohort of patients who have become resistant to alectinib or alectinib and crizotinib.
Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). 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.
Contact:
Kazumi Kobayashi
Tel: +81 (0) 3-3278-2095
Email: kazumi.kobayashi@takeda.com
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