Chugai Pharmaceutical Co., Ltd. announced that the Ministry of Health, Labour and Welfare  has approved today the additional indication of Alecensa® (generic name: alectinib), a Chugai originated antineoplastic agent/ALK inhibitor, for “adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer.” The application for regulatory approval for Alecensa was filed in December 2023, followed by an orphan drug designation subject to priority review, in the same month.

“We are very pleased that Alecensa, a Chugai originated medicine, received approval in Japan following the U.S. and Europe for the additional indication of adjuvant therapy for ALK-positive NSCLC. In early-stage NSCLC, approximately half of patients who received tumor resection surgery may experience recurrence. With this additional indication, we are confident in not only reducing the risk of post-operative recurrence but also being able to expect complete cure and long-term survival in patients with ALK-positive NSCLC in Japan. We believe this greatly improves the quality of life for patients and their families. We will continue working to promptly provide proper use information,” said Chugai’s President and CEO, Dr. Osamu Okuda.

The approval is based on results from the ALINA study, a global Phase 3 study conducted in patients with completely resected ALK-positive early NSCLC stage IB (tumors ≥ 4 cm) to IIIA (UICC/AJCC 7th edition). In the study, 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 with platinum-based chemotherapy in people with completely resected IB to IIIA ALK-positive NSCLC.1 The safety and tolerability of Alecensa in the ALINA trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed.1

Chugai Pharmaceutical, a leading oncology company, is committed to promoting the proper use of Alecensa so that it can contribute to the treatment of ALK-positive early non-small cell lung cancer as a new treatment option in the adjuvant setting.

 

Source: pharm.co.jp

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