Oncology-focused drug development company Curis has obtained the conditional approval for Erivedge (vismodegib) to treat adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy in the European Union (EU).
The approval, which is applicable to all 28 EU member states, has triggered $6m milestone payment to Curis from Genentech, a member of the Roche Group.
Curis is even eligible for potential sales-based royalties of Erivedge, while Roche is responsible for commercialization activities in the EU.
Commenting on the approval, Curis chief executive officer Dan Passeri said Erivedge is the first approved medicine in the EU for patients with advanced basal cell carcinoma.
"Roche's development and commercialization efforts have significantly expanded global patient access and the market opportunity for Erivedge, with regulatory approvals for Erivedge in the United States, Switzerland, Australia, Israel, South Korea, Mexico, and Ecuador, in addition to the EU," Passeri added.
"We expect that Roche will seek approval of Erivedge in several other territories and anticipate that these efforts will continue to expand the number of patients that will have access to this important medicine in the near future."
Under the provisions of the conditional approval, Roche will provide more safety data on Erivedge in advanced BCC from an ongoing study.
Designed to selectively target the Hedgehog signaling pathway, Erivedge was discovered by Genentech and jointly validated by Genentech and Curis.
