Chugai gains new Japanese approval for Alecensa

21 May 2026

Japan’s Chugai Pharmaceutical (TYO: 4519) revealed that it received regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for the additional indication of its anti-cancer agent/ALK inhibitor Alecensa (alectinib) for advanced or recurrent ALK fusion gene-positive solid tumors, including pediatric patients.

This is the world’s first tumor-agnostic approval for an ALK inhibitor, said Chugai, which is majority owned by Swiss pharma giant Roche (ROG: SIX). Chugai reported sales of 33.5 billion yen ($210.6 million) in 2025 for Alecensa.

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