San Diego-based Tocagen Inc. said its lead product candidate to treat the most common form of brain cancer received the European Medicines Agency's orphan drug designation.
Toca 511 & Toca FC is undergoing a late-stage clinical trial to potentially treat glioblastoma, a high-grade glioma. The two-part treatment is made up of vocimagene amiretrorepvec and flucytosine.
About 190,000 patients worldwide are expected to be diagnosed with this form of cancer in 2018, with about 36,000 of them in Europe.
The EMA's orphan designation aims to facilitate developing medicines for rare diseases. It is granted to medicines that target a condition affecting fewer than 5 in 10,000 people in the EU.
Orphan medicines are eligible for conditional marketing authorization; 10-year market exclusivity in the EU after a product's approval; and fee waivers, such as the marketing authorization application fee, among other incentives.
