FDA approves rare tumor drug Romvimza

The US Food and Drug Administration (FDA) has approved Romvimza (vimseltinib), from Deciphera Pharmaceuticals, a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

Deciphera, a wholly-owned subsidiary of Japan’s Ono Pharmaceutical (TYO: 4528), plans to make Romvimza commercially available in the US next week.

“The FDA approval of Romvimza for TGCT is a crucial advancement for the TGCT community and we believe Romvimza has the potential to become the new standard of care for people with TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity. This is also an important milestone for our organization, as it is the second approved therapy discovered using Deciphera’s proprietary switch-control kinase inhibitor platform,” said Ryota Udagawa, president and chief executive of Deciphera Pharmaceuticals.