FDA approved Roche’s oral hedgehog pathway inhibitor Erivedge (vismodegib), for the treatment of adult patients with advanced metastatic or relapsed basal cell carcinoma. The approval is the first by FDA for a drug for metastatic basal cell carcinoma.
Regulatory clearance in the U.S. was based on data from the pivotal, open-label Phase II Erivance BCC trial (SHH4476g), which included 104 patients with either locally advanced or metastatic BCC who either weren’t suitable for surgery or radiotherapy, or whose cancers had returned after surgery or radiotherapy. The overall response rate following Erivedge therapy was 43% for patients with locally advanced BCC, and 30% for patients with metastatic BCC. The median duration of response was 7.6 months. A European marketing authorization application for the drug has separately been submitted.
Erivedge was originally discovered by Roche’s Genentech, and was jointly validated by Genentech and Curis through preclinical studies. In 2003 Curis granted Genentech an exclusive, global, royalty-bearing license (and sublicensing rights), to develop and commercialize small molecule and antibody Hedgehog pathway inhibitors.
Genentech is developing Erivedge in the U.S., with Roche taking responsibility for ex-U.S. markets excluding Japan and Korea, and Chugai Pharmaceuticals covering these latter two territories. Under terms of the 2003 agreement Curis is eligible to receive cash payments upon the successful achievement of specified clinical development and regulatory approval milestones, as well as royalties upon commercialization of Erivedge. The firm says such payments could reach $115 million relating to the development of vismodegib or another small molecule, dependent on the achievement of specific clinical development and regulatory objectives.
In August 2011 FDA approved another Roche skin cancer drug, Zelboraf™ (vemurafenib), for the treatment of BRAF V600E mutation-positive, inoperable, or metastatic melanoma. The agency in parallel approved the firm’s cobas 4800 BRAF V600 Mutation Test identify patients eligible for Zelboraf treatment.