BERLIN (dpa-AFX) - Merck Monday announced that the European Commission (EC) granted marketing authorization for Ogsiveo (nirogacestat), an oral gamma secretase inhibitor, as monotherapy for the treatment of adults with progressing desmoid tumors who require systemic treatment.
Ogsiveo is the first and only therapy approved in the European Union (EU) to treat desmoid tumors. The approval was issued to SpringWorks Therapeutics Inc., a healthcare company of Merck.
'Desmoid tumors can have a profound impact on people's lives and are difficult to manage due to their invasive nature and high rates of recurrence. Until now, there have been no approved medicines in Europe,' said Bernd Kasper, M.D., Ph.D., Professor, University of Heidelberg, Mannheim Cancer Center, Mannheim, Germany, and principal investigator of the DeFi trial. 'OGSIVEO is a highly innovative therapy with efficacy data demonstrating both meaningful antitumor activity and a significant improvement in desmoid tumor symptoms, including a significant reduction in pain which is the most debilitating symptom reported by patients.'
Desmoid tumors are rare, locally aggressive tumors that form in the connective tissues of the body. Approximately 1,300 to 2,300 new cases of desmoid tumors are diagnosed annually in the EU.
These tumors can cause severe pain, limited function, loss of mobility, disfigurement and fatigue. They are challenging to manage because of their unpredictable nature and high rate of recurrence, which can significantly impact an individual's quality of life.
The EC approval of Ogsiveo is based on results from the Phase 3 DeFi trial, which enrolled 142 adult patients with progressing desmoid tumors and met the primary endpoint of improving progression-free survival (PFS). Ogsiveo demonstrated a statistically significant improvement over placebo with a 71% reduction in the risk of disease progression.
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