Oncology-focused company Curis announced today that the Committee for Medicinal Products for Human Use (NASDAQ:CHMP) of the European Medicines Agency (NYSEMKT:EMA) has recommended conditional approval of Erivedge (vismodegib) for treating adult patients with symptomatic metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that is not appropriate for surgery or radiotherapy. Receiving conditional approval would make Erivedge Europe's first licensed treatment for patients with advanced basal cell carcinoma, which is a rare form of skin cancer that can be disfiguring, debilitating, and even fatal.
"We are extremely pleased that the CHMP has recommended the conditional approval of Erivedge in the EU and we hope that this important medicine will soon be available to patients in Europe," said Curis CEO Dan Passeri. "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. 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. We view Roche's broad efforts to expand patient access to Erivedge as a testament to its commitment to this important, first-in-class molecule."
Possessing the authority to approve medicines for use in the European Union, the European Commission generally delivers final decisions within three months of the CHMP recommendation. The final decision will apply to all 27 member states of the EU. A conditional approval from the European Commission would mean a $6 million milestone payment for Curis from Genentech, which is a member of the Roche Group. The Roche Group is responsible for the commercialization of Erivedge in the EU.
Based on quality, safety, and submitted efficacy data, the CHMP stated it considers there to be a favorable benefit-to-risk balance for Erivedge and, therefore, recommended the granting of marketing authorization, which is conditional and will require submission of additional data from ongoing studies. The CHMP grants conditional approval for medicinal products that fulfill an unmet medical need.
For more information, visit www.curis.com
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