Drugs and FDA
FDA approves Merck KGaA’s pimicotinib for joint tumors
The FDA approved pimicotinib for adults with symptomatic TGCT when surgery may worsen functional limitation or cause severe morbidity.
The FDA approved pimicotinib, sold as Pimjetmi, for adults with symptomatic tenosynovial giant cell tumor (TGCT) when surgical removal may cause worsening functional limitation or severe morbidity. MedCity News reported that Merck KGaA will market the drug.
In the MANEUVER trial, the FDA said the overall response rate at Week 25 was 56% (95% CI: 42, 68) with pimicotinib and 3.2% (95% CI: 0.1, 17) with placebo. The FDA also reported statistically significant improvements in range of motion, pain and physical functioning. Common adverse reactions included pruritus, rash, face edema and fatigue. The prescribing information includes warnings for hepatotoxicity, embryo-fetal toxicity and increased serum creatinine without affecting renal function.
