EC 821-541-6
Also known as Alecensa.
Approval allows FoundationOne CDx to detect BRAF V600 alterations and BRAF fusion genes to guide tovorafenib treatment in glioma and expands companion indications to nine cancer types.
Japan approves tumor‑agnostic ALK inhibitor for ALK‑fusion solid tumors including pediatrics. TACKLE Phase II showed 70–76% response in ALK‑fusion cases; safety consistent. FoundationOne CDx approved.
TACKLE Phase II supported Alecensa's efficacy/safety, enabling a partial marketing-authorization change; FoundationOne CDx expands tumor-agnostic genomic profiling and treatment options.
Roche presents over 30 abstracts on cancer treatments, including breast, lung, and bladder cancers, at ESMO 2025, showcasing significant advancements in progression-free and overall survival.
