SpringWorks Therapeutics, a subsidiary of Merck KGaA based in Darmstadt, Germany, announced that the European Commission has approved OGSIVEO for adults with progressing desmoid tumors requiring medical treatment. This approval marks the first authorized therapy in the European Union specifically for desmoid tumors.
Dr. Bernd Kasper, professor at the University of Heidelberg and lead investigator of the DeFi trial, stated, “Desmoid tumors greatly impact patients’ lives because they are invasive and tend to come back. There was no approved treatment in Europe before. OGSIVEO provides meaningful tumor control and notable symptom relief, especially pain reduction, which is one of the hardest symptoms for patients to manage.”
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Lynne Hernandez, Executive Director of the Desmoid Tumor Research Foundation, added, “This approval is a big step forward for patients, families, and healthcare professionals in Europe. We hope it raises awareness, leads to quicker diagnoses, and helps improve outcomes with an official treatment now available.”
Desmoid tumors are rare soft tissue growths that aggressively develop in connective tissues. Around 1,300 to 2,300 new cases are diagnosed annually in the EU. These tumors cause severe pain, limited mobility, changes in appearance, and fatigue. Their unpredictable growth and high recurrence make management difficult. Experts now recommend medical treatments as the primary approach over surgery for most tumors needing intervention.
Danny Bar-Zohar, MD, CEO of Healthcare and Executive Board Member at Merck KGaA, expressed gratitude, saying, “We thank the patients, families, researchers, and support groups who helped make this approval possible. OGSIVEO is already the standard treatment for desmoid tumors in the US, and we’re proud to bring the same benefits to European patients. After recently gaining approval for our treatment in NF1-PN, we are launching two new therapies, underscoring our commitment to rare tumor communities.”
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The approval is based on results from the Phase 3 DeFi trial involving 142 adults with progressing desmoid tumors. The study showed OGSIVEO significantly improved progression-free survival, reducing the risk of disease progression by 71 percent compared to placebo. It also increased the objective response rate to 41 percent versus 8 percent for placebo. Responses occurred faster, with a median of 5.6 months compared to 11.1 months on placebo. Patients reported less pain, improved symptoms, better physical functioning, and enhanced quality of life. The treatment demonstrated a manageable safety profile with common side effects including diarrhea, rash, ovarian toxicity in women of childbearing age, nausea, fatigue, low phosphate levels, headaches, and mouth sores.
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