Aduro’s CRS-207 for Mesothelioma Wins Orphan Drug Status From EMA
The European Medicines Agency has granted Aduro Biotech’s mesothelioma candidate orphan drug designation.
Given orphan status by the FDA in March, CRS-207 immunotherapy is being tested alongside standard chemotherapy in a Phase 1b study for patients with malignant pleural mesothelioma. The drugmaker says it will launch a similar Phase 3 trial in the first half of next year, skipping mid-stage research to propel the candidate forward.
The EMA decision offers sponsors special protections designed to spur development in rare diseases, including scientific advice and up to 10 years of EU marketing exclusivity.
Aduro says the designation will benefit the company as it grows its presence in the European market.