Introduction to Alecensa Indication Expansion
According to a news article (中外製薬 アレセンサで小児含むALK陽性固形がんの適応拡大を申請 | ニュース | ミクスOnline) published by MIX Online on June 27, 2025, Chugai Pharmaceutical has submitted a supplemental application to expand the indication of Alecensa (alectinib hydrochloride) to include unresectable, advanced, or recurrent solid tumors harboring ALK fusion genes, including pediatric patients. If approved, this would make Alecensa the world’s first tumor-agnostic therapy specifically targeting ALK fusion-positive solid tumors — a significant milestone in precision oncology.
Current Approved Indications and Rationale for Expansion
Alecensa is currently approved in Japan for ALK-positive non-small cell lung cancer (NSCLC) and anaplastic large cell lymphoma (ALCL). The proposed expansion aims to leverage molecular targeting data and address broader unmet needs across solid tumor types, moving beyond organ-specific approvals and reinforcing Chugai’s precision oncology strategy.
Key Clinical Evidence from Investigator-Initiated TACKLE Study
This application is based on data from the domestic Phase II TACKLE study, an investigator-initiated trial (IIT) conducted at the National Cancer Center Hospital under the MASTERKEY Project. The study included 26 patients with various ALK fusion-positive solid tumors. The primary endpoint was objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), overall survival (OS), and safety. The IIT demonstrated promising efficacy and manageable safety in this difficult-to-treat patient population, providing the basis for the tumor-agnostic submission.
Chugai’s Strategic Perspective
Chugai’s President and CEO, Dr. Osamu Okuda, emphasized that this filing represents an important milestone in expanding treatment options for patients with rare or refractory ALK-driven tumors. The company is committed to accelerating review timelines to enable rapid patient access, aligning with its vision for advancing personalized healthcare.
Conclusion
If approved, Alecensa will offer a first-in-class tumor-agnostic option for ALK fusion-positive solid tumors, including pediatric indications. This development underscores the increasing role of biomarker-driven approaches in oncology and highlights Chugai’s leadership in driving innovative treatment strategies to address high unmet medical needs.