The FDA approved EMD Serono’s Pimjetmi on Nov. 10 for adults with symptomatic tenosynovial giant cell tumor for whom surgical removal could worsen functional limitations or cause severe complications.
The approval was based on the phase 3 MANEUVER trial, which evaluated pimicotinib, a kinase inhibitor, against placebo in patients with symptomatic tumors. The international study was randomized 2:1 and double-blind.
At Week 25, the overall response rate was 56% among patients receiving Pimjetmi, compared with 3.2% in the placebo group. Median duration of response was not reached in the Pimjetmi arm. Among patients who responded to treatment, 91% maintained their response for at least six months and 77% for at least 12 months.
Patients receiving Pimjetmi also experienced statistically significant improvements at Week 25 in active range of motion of the affected joint, worst pain and physical functioning compared with placebo.
Adverse reactions reported in more than 20% of patients included itching, rash, facial swelling, periorbital edema, fatigue, nausea, headache and peripheral edema. The drug’s prescribing information includes warnings for liver toxicity, embryo-fetal toxicity and increased serum creatinine without affecting kidney function.
The recommended dosage is 50 mg orally once daily. The drug previously received FDA fast track and breakthrough therapy designations.
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