EZMEKLY

SpringWorks Therapeutics’ EZMEKLY® (mirdametinib) received conditional EU approval for NF1-PN in adults and children (2+), marking the first and only EU-approved therapy for this rare genetic disorder. Backed by Phase 2b ReNeu trial data (n=114), EZMEKLY showed objective response rates of 41% in adults and 52% in pediatric patients, with ~41-42% median tumor volume reduction and durable responses. Available in capsule and dispersible tablet forms, EZMEKLY addresses a significant unmet need in an estimated 135,000 EU patients.