FDA Approves Ono’s Romvimza for Rare Joint Tumor, Challenging Daiichi Sankyo’s Turalio
The FDA has approved Ono Pharmaceutical's Romvimza (vimseltinib) for the treatment of tenosynovial giant cell tumor (TGCT) in adults12.
Romvimza is indicated for TGCT cases where surgical resection could potentially worsen functional limitations or cause severe morbidity5.
This approval introduces competition to Daiichi Sankyo's Turalio (pexidartinib), which was the first FDA-approved systemic therapy for TGCT in 201927.
Romvimza is administered orally twice weekly, compared to Turalio's twice-daily dosing schedule, potentially offering a dosing advantage2.
Unlike Turalio, which carries a black box warning for liver toxicity and requires a REMS program, Romvimza does not require a REMS program but still needs liver enzyme monitoring2.
In the pivotal MOTION Phase 3 study, Romvimza demonstrated a 40% objective response rate at week 25, compared to 0% for placebo58.
Ono Pharmaceutical acquired Romvimza through its $2.4 billion acquisition of Deciphera Pharmaceuticals in 202415.
TGCT is a rare, non-malignant tumor affecting joints, causing pain, swelling, and limited movement17.
GlobalData forecasts Romvimza to generate $152 million in global sales by 2030, compared to $54 million for Turalio2.
The approval of Romvimza represents a significant advancement for TGCT patients, offering a new treatment option with a different safety profile from the existing therapy8.
Sources:
1. https://medcitynews.com/2025/02/ono-pharma-fda-approval-vimseltinib-romvimza-deciphera-tgct-csf1-rare-tumor/
2. https://www.pharmaceutical-technology.com/news/onos-tgct-therapy-wins-fda-approval-challenging-daiichi-sankyo/
5. https://www.fiercepharma.com/pharma/fda-approves-onos-rare-tumor-drug-24b-deciphera-buyout
7. https://www.daiichisankyo.com/media/pressrelease/detail/index3177.html
8. https://www.biospace.com/press-releases/u-s-fda-grants-full-approval-of-decipheras-romvimza-vimseltinib-for-the-treatment-of-symptomatic-tenosynovial-giant-cell-tumor-tgct