- MHLW approved alectinib (Alecensa) for tumor‑agnostic use in ALK fusion–positive advanced or recurrent solid tumors, including pediatric patients.
- TACKLE, an investigator‑initiated Japanese Phase II (n=26), showed 70.0% response (7/10) in the ALK‑fusion main cohort and 76.5% pooled (13/17); full analysis set response was 43.8% (7/16).
- Safety: 73.1% had adverse events (19/26); lymphocyte and neutrophil counts decreased 23.1% each (6/26), anemia 19.2% (5/26), and increased creatinine 15.4% (4/26).
- FoundationOne CDx was approved for expanded use as the companion diagnostic for Alecensa on March 9, 2026.
Approval
MHLW approved alectinib (Alecensa) for ALK fusion–positive advanced or recurrent solid tumors, including pediatric patients, marking the first tumor‑agnostic approval for an ALK inhibitor.
Clinical evidence
TACKLE, an investigator‑initiated, multicenter, open‑label Phase II in Japan (n=26) of unresectable rare cancers with ALK abnormalities, used response rate as primary endpoint: main cohort FAS 43.8% (7/16); ALK‑fusion subcohort 70.0% (7/10); pooled ALK‑fusion across cohorts 76.5% (13/17).
Safety
Adverse events occurred in 73.1% (19/26); main events were decreased lymphocyte and neutrophil counts 23.1% each (6/26), anemia 19.2% (5/26) and increased creatinine 15.4% (4/26); no new safety signals versus prior Alecensa data.
Companion diagnostic and dosing
FoundationOne CDx was approved for expanded use as the companion diagnostic on March 9, 2026; adult dose 300 mg orally twice daily; pediatric weight‑based dosing: ≥6–<15 kg 150 mg once daily, ≥15–<25 kg 300 mg/day (150 mg twice), ≥25–<35 kg 450 mg/day (300 mg morning/150 mg evening), ≥35 kg 600 mg/day (300 mg twice).
