PIMJETMI approved by FDA for rare joint tumor, Merck says

PIMJETMI, Merck's pimicotinib treatment, has been approved by the U.S. Food and Drug Administration for adults with symptomatic tenosynovial giant cell tumor when surgical removal may worsen functional limitation or cause severe morbidity, Merck said Tuesday.

Merck described PIMJETMI as a once-daily oral colony stimulating factor-1 receptor inhibitor and a systemic treatment option for eligible U.S. patients.

The company said the approval was based on primary and longer-term results from the global Phase 3 MANEUVER study. In that trial, Merck said PIMJETMI had an objective response rate of 56% at week 25, compared with 3% for placebo, assessed by a blinded independent review committee using RECIST v1.1.

Merck said tenosynovial giant cell tumor is a rare, locally aggressive tumor that occurs in or around joints and can cause pain and reduced mobility.