The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has announced positive opinion for conditional approval of Curis' Erivedge in European Union.
Erivedge (vismodegib) is used to treat adults with symptomatic metastatic basal cell carcinoma, or locally advanced basal cell carcinoma not suitable for surgery or radiotherapy.
Curis chief executive officer Dan Passeri said the company expects the availability of the Erivedge to patients in Europe soon.
"We continue to be pleased by the strength of Roche's global regulatory and commercialization efforts regarding Erivedge, which we anticipate will significantly broaden patient access to Erivedge globally," Passeri added.
"Erivedge is currently under review for approval by health authorities in several countries outside of Europe, and regulatory submissions are planned in many additional countries."
Upon obtaining conditional approval, Erivedge that targets Hedgehog signaling pathway becomes the first licensed treatment in Europe for advanced basal cell carcinoma patients.