Merck’s SpringWorks Therapeutics gains European approval for Ogsiveo
The drug is the first treatment for desmoid tumours to be approved in the region.
Merck KGaA’s rare cancer company has won European approval for Ogsiveo (nirogacestat), making it the first licensed treatment for desmoid tumours in the region.
SpringWorks Therapeutics’ oral gamma secretase inhibitor is now indicated in Europe for adults with progressing desmoid tumours who require systemic treatment, following its 2023 approval by the US Food and Drug Administration (FDA).
Danny Bar-Zohar, Healthcare CEO at Merck, said: “Ogsiveo is already established as the standard of care systemic therapy for desmoid tumours in the US, and our goal is to bring the same treatment benefits to patients in Europe.
“Following last month’s European Commission approval of our therapy for patients with NF1-PN, we are in the unique position of launching two innovative treatments – underscoring our commitment to the rare tumour patient community.”
Ogsiveo’s European approval was based on results from the phase 3 DeFi trial of 142 adults with progressing desmoid tumours. The study met its primary endpoint of improving progression-free survival (PFS), showing a statistically significant improvement over placebo with a 71% reduction in the risk of disease progression.
Desmoid tumours are rare but locally aggressive and form in the connective tissues of the body, with up to 2,300 new cases typically diagnosed in the EU each year.
Bernd Kasper, a Professor at the University of Heidelberg’s Mannheim Cancer Center in Germany and principal investigator of the DeFi trial, said: “Desmoid tumours can have a profound impact on people’s lives and are difficult to manage due to their invasive nature and high rates of recurrence.
“Ogsiveo is a highly innovative therapy with efficacy data demonstrating both symptoms, including a significant reduction in pain which is the most debilitating symptom reported by patients.”
We are in the unique position of launching two innovative treatments – underscoring our commitment to the rare tumour patient community.”
Merck’s SpringWorks company also recently won European approval for Ezmekly (mirdametinib) for the treatment of symptomatic, inoperable plexiform neurofibromas in patients with neurofibromatosis type 1 (NF1-PN) aged two and older.
The rare genetic disorder affects around 135,000 people in the EU, and can cause disfigurement, pain and disability.
