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American Society of Clinical Oncology stories

Nov 10, 2026

FDA approves Merck KGaA's pimicotinib for tenosynovial giant cell tumor

The FDA has approved pimicotinib (Pimjetmi, EMD Serono) for treating symptomatic tenosynovial giant cell tumors where surgery would worsen functional limitations, marking another win for Merck KGaA's rare tumor strategy.

Nov 10, 2026·3 sources

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Top claims

▪Merck KGaA expanded its rare tumor portfolio by acquiring SpringWorks Therapeutics for $3.9 billion in 2025 and striking a $1.1 billion deal for Silence Therapeutics last month
▪At a median follow-up of 14.3 months in the Phase 3 MANEUVER trial, the overall response rate for pimicotinib reached 76.2%, with nearly 94% of patients experiencing tumor size reduction
▪Pimicotinib is administered as a 50 mg oral pill taken once daily with or without food

Topics

FDA drug approval Clinical trials Rare diseases Cancer & Oncology Drug Policy, Pricing & Approval Pharmaceutical Industry Targeted cancer therapy

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