FDA approved Romvimza (vimseltinib) for Symptomatic Tenosynovial Giant Cell TumorFDA approved new drug Romvimza for rare joint tumor condition.

Not reported in label.

ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

The recommended dosage is 30 mg orally twice weekly, with a minimum of 72 hours between doses, as directed on the blister package. Instruct patients to follow the schedule on the blister package and to take ROMVIMZA on the same days each week. ROMVIMZA may be taken with or without food. Swallow capsules whole; do not open, break, or chew. If a dose is missed by 48 hours or less, take the missed dose as soon as possible and take the next dose on its regularly scheduled day. If a dose is missed by more than 48 hours, skip the missed dose and take the next dose on its regularly scheduled day. If vomiting occurs within 30 minutes of taking a dose, repeat that dose. Otherwise, take the next dose on its regularly scheduled day. Dose reductions for adverse reactions: first reduction to 20 mg twice weekly, second to 14 mg twice weekly. Permanently discontinue if unable to tolerate 14 mg twice weekly. For hepatotoxicity, see Table 2 in label for specific modifications. Avoid concomitant use with P-gp substrates; if unavoidable, administer ROMVIMZA at least 4 hours before the P-gp substrate.

Efficacy was evaluated in MOTION (NCT05059262), a phase 3, double-blind, multicenter, randomized (2:1), placebo-controlled study in patients with TGCT for whom surgical resection may cause worsening functional limitation or severe morbidity. Eligible patients had confirmed TGCT with measurable disease per RECIST v1.1 with at least one lesion ≥2 cm. Patients were randomized to placebo or ROMVIMZA 30 mg twice weekly for 24 weeks. Stratification by tumor location (lower limb vs all other) and region (US vs non-US). At Week 25, patients could enter an open-label extension. Major efficacy outcome: overall response rate (ORR) by blinded independent radiological review per RECIST v1.1 at Week 25. Additional outcomes: ORR by tumor volume score, mean change in active range of motion, change in PROMIS-PF score, and BPI Worst Pain response. A total of 123 patients were randomized (83 to ROMVIMZA, 40 to placebo). Median age 44 years (range 20-78); 59% female; 65% White, 4% Asian, 3% Black or African American, 28% not reported or unknown.

Not reported in label.

Not reported in label.