Merck eyes global filing as TGCT drug shows strong QoL impact

Merck KGaA is advancing its CSF-1R inhibitor pimicotinib toward global approval after a Phase III trial in TGCT patients delivered promising efficacy and functional outcomes. With a tumour volume response rate of 61.9%—surpassing Turalio and approaching Romvimza—the real differentiator may be quality-of-life gains. Patients saw significant improvements in mobility, stiffness, and pain, a critical edge in treating this non-fatal but debilitating disease.

Toxicity data also offers a commercial advantage. While all patients experienced adverse events, only a small percentage were serious, and there were no signs of liver damage—an issue that has impacted competitors in this space.

Merck now holds global rights to pimicotinib and is pursuing approvals in China and the US. While forecasted sales remain modest compared to Romvimza, the therapy’s QoL benefits and favourable safety profile may position it as a preferred option in a niche but underserved market.

Read the full breakdown of the data and market implications.