FDA Approves Ono Pharmaceutical’s Romvimza for Rare Joint Tumor

The FDA has approved Romvimza (vimseltinib) for adult patients with symptomatic tenosynovial giant cell tumor (TGCT)8.

Romvimza is indicated for TGCT cases where surgery could potentially worsen a patient's bodily function or morbidity1.

The drug is a CSF1R inhibitor, similar to Daiichi Sankyo's Turalio, which was the first FDA-approved therapy for TGCT in 20191.

Ono Pharmaceutical acquired Deciphera Pharmaceuticals for $2.4 billion in 2024, gaining Romvimza as part of the deal23.

The approval is based on the Motion trial, where Romvimza showed a 40% response rate in TGCT patients at week 25, compared to 0% for placebo1.

Romvimza's safety profile is described as "clean and well-characterized," potentially giving it an advantage over Turalio, which carries a black box warning for liver injury7.

The acquisition of Deciphera is part of Ono's strategy to expand its oncology portfolio and accelerate its business development in the U.S. and Europe2.

TGCT is a rare, non-malignant tumor that forms near joints and can lead to significant disability if left untreated8.

Ono Pharmaceutical is also seeking approval for Romvimza from the European Medicines Agency8.

Sources:

1. https://www.fiercepharma.com/pharma/fda-approves-onos-rare-tumor-drug-24b-deciphera-buyout

2. https://www.fiercepharma.com/pharma/japans-ono-pays-24-billion-qinlock-maker-deciphera

3. https://www.biopharmadive.com/news/deciphera-ono-deal-acquire-cancer-drug-kinase/714538/

7. https://www.biospace.com/ono-to-buy-deciphera-for-2-4b-looks-to-expand-cancer-pipeline-and-us-footprint

8. https://www.tabletscapsules.com/3639-News/617766-FDA-Approves-Ono-Kinase-Inhibitor-for-Rare-Cancer/