Chugai Pharmaceutical has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an additional indication for its anti-cancer drug Alecensa (generic name: alectinib) for the treatment of advanced or recurrent ALK fusion gene-positive solid tumours, including paediatric patients. The approval marks the world’s first tumour-agnostic approval granted for an ALK inhibitor.

The approval expands Alecensa’s use beyond its existing indications in Non-Small Cell Lung Cancer (NSCLC) and anaplastic large cell lymphoma, enabling treatment for patients with a broad range of ALK fusion-positive cancers irrespective of tumour origin.

Dr. Osamu Okuda, President and CEO of Chugai Pharmaceutical, said the approval represents a milestone in personalised cancer treatment. He stated that the expanded indication would provide a new treatment option for patients across multiple cancer types and age groups, while reinforcing the company’s commitment to precision medicine.

The regulatory decision was based on data from the Japanese phase 2 TACKLE study, an investigator-initiated clinical trial evaluating the efficacy and safety of Alecensa in paediatric and adult patients with rare cancers harbouring ALK gene abnormalities, including fusion or rearrangement genes, activating mutations and gene amplification.

According to the study results, the primary endpoint of response rate assessed by an independent central review committee reached 43.8 percent in the main cohort. Among patients with ALK fusion-positive tumours, the response rate increased to 70 percent, while the pooled analysis across all study cohorts demonstrated a response rate of 76.5 percent in ALK fusion-positive patients. These efficacy outcomes formed the primary basis for the approval.

The safety analysis showed adverse events in 73.1 percent of patients, with the most common side effects including decreased lymphocyte count, decreased neutrophil count, anaemia and elevated blood creatinine levels. Chugai stated that the safety profile remained consistent with previously established data for Alecensa and no new safety signals were identified during the study.

The company also noted that FoundationOne CDx Cancer Genomic Profile has been approved in Japan as a companion diagnostic tool to identify patients who may benefit from Alecensa treatment for ALK fusion-positive solid tumours. The expanded diagnostic approval was granted by the MHLW in March 2026.

The TACKLE study was conducted as part of the MASTER KEY project, an industry-academia collaboration led by Japan’s National Cancer Center Hospital aimed at accelerating treatment development for rare cancers. The trial involved four Japanese institutions, including Kyoto University Hospital, Kyushu University Hospital and Hokkaido University Hospital.

ALK fusion or rearrangement genes are formed through chromosomal translocations involving the ALK gene and other partner genes, resulting in abnormal proteins that can drive tumour growth. Such genetic alterations have been identified in several cancer types, including lung, breast and colorectal cancers, as well as inflammatory myofibroblastic tumours.

Alecensa is an oral ALK inhibitor discovered by Chugai and is known for its high selectivity and activity in the central nervous system. The drug is currently approved in more than 100 countries for first-line and second-line treatment of ALK-positive metastatic NSCLC, including approvals in the United States, Europe, Japan and China. In Japan, Alecensa is also approved for recurrent or refractory ALK-positive anaplastic large cell lymphoma.