Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) has announced that the Ministry of Health, Labour and Welfare (MHLW) has approved Alecensa® (generic name: alectinib) for the additional indication of “adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer” in Japan. The regulatory application for Alecensa was submitted in December 2023, and it received orphan drug designation with priority review in the same month.
“We are thrilled that Alecensa, developed by Chugai, has received approval in Japan for the adjuvant treatment of ALK-positive NSCLC, following its approvals in the U.S. and Europe. In early-stage NSCLC, about half of patients who undergo tumor resection surgery may face recurrence. This new indication not only aims to reduce the risk of post-operative recurrence but also holds the potential for complete cure and long-term survival for ALK-positive NSCLC patients in Japan. We believe this approval significantly enhances the quality of life for patients and their families,” said Dr. Osamu Okuda, President and CEO of Chugai.
The approval is based on the ALINA study, a global Phase 3 trial involving patients with completely resected ALK-positive early NSCLC (stage IB with tumors ≥ 4 cm to IIIA, UICC/AJCC 7th edition). The study showed that Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared to platinum-based chemotherapy. The safety and tolerability of Alecensa in the ALINA trial were consistent with previous studies conducted in metastatic settings, with no new safety concerns observed.
Chugai Pharmaceutical, a leading company in oncology, remains dedicated to ensuring the appropriate use of Alecensa, aiming to advance treatment options for ALK-positive early non-small cell lung cancer in the adjuvant setting.
