European Approval for ROMVIMZA™ Provides Major Boost to Deciphera

Deciphera Pharmaceuticals has achieved a pivotal regulatory victory with the European Commission granting marketing authorization for its drug ROMVIMZA. The approval, issued on September 17, 2025, covers the treatment of symptomatic tenosynovial giant cell tumor (TGCT) in adult patients for whom surgery is not a viable option. This long-awaited decision represents a transformative milestone for the biotechnology firm, which now operates as part of Ono Pharmaceutical.

The authorization is founded on compelling clinical evidence. Study data demonstrated that after 97 weeks, 23% of patients treated with the drug’s active substance, vimseltinib, achieved a complete response. The trial successfully met its primary endpoints at the 25-week mark, showing statistically significant improvements in range... Read more...