• #25: Romvimza Receives FDA Approval for TGCT Treatment

  • 2025/02/21
  • 再生時間: 5 分
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#25: Romvimza Receives FDA Approval for TGCT Treatment

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  • Ono Pharmaceutical's Romvimza has been approved by the FDA for treating adult patients with symptomatic tenosynovial giant cell tumor (TGCT) when surgery is not a viable option. This provides another option for patients, in addition to Daiichi Sankyo’s Turalio, as both drugs inhibit the colony-stimulating factor 1 receptor (CSF1R). The approval was based on the MOTION trial, where Romvimza showed a 40% response rate at Week 25, compared to 0% for placebo, and also demonstrated improvements in range of motion, physical functioning, and pain. Ono acquired Romvimza through the purchase of Deciphera Pharmaceuticals. Romvimza offers a more convenient dosage of 30 mg twice weekly compared to Turalio's 250 mg twice daily. Notably, Turalio carries a black box warning and REMS program due to liver injury concerns, while Romvimza does not have either.

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あらすじ・解説

Ono Pharmaceutical's Romvimza has been approved by the FDA for treating adult patients with symptomatic tenosynovial giant cell tumor (TGCT) when surgery is not a viable option. This provides another option for patients, in addition to Daiichi Sankyo’s Turalio, as both drugs inhibit the colony-stimulating factor 1 receptor (CSF1R). The approval was based on the MOTION trial, where Romvimza showed a 40% response rate at Week 25, compared to 0% for placebo, and also demonstrated improvements in range of motion, physical functioning, and pain. Ono acquired Romvimza through the purchase of Deciphera Pharmaceuticals. Romvimza offers a more convenient dosage of 30 mg twice weekly compared to Turalio's 250 mg twice daily. Notably, Turalio carries a black box warning and REMS program due to liver injury concerns, while Romvimza does not have either.

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