Roche has been boosted by the news that regulators in the USA have given priority review status to its investigational skin cancer drug vismodegib.
The US Food and Drug Administration has agreed to look at the company’s New Drug Application for vismodegib for the treatment of adults with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. The priority review means that the agency has given an action date to decide on approval of March 8, 2012.
Vismodegib is a first-in-class oral treatment that selectively inhibits signalling in the Hedgehog pathway, “which is implicated in more than 90% of BCC cases,” Roche notes. Chief medical officer Hal Barron said that “we hope to provide people with the first FDA-approved medicine for this potentially disfiguring, and in some cases fatal, disease as soon as possible”.
The application is based on results from the ERIVANCE BCC study, which showed vismodegib substantially shrank tumours or healed visible lesions in 43% of patients with locally advanced BCC and 30% of patients with metastatic BCC. The median progression-free survival for both metastatic and locally advanced BCC patients was 9.5 months.
The acceptance by the FDA of the file triggers an $8 million milestone payment to US biotech Curis, vismodegib’s originator. The news follows the recent FDA approval granted to Roche’s Zelboraf (vemurafenib), a personalised medicine designed for use in melanoma patients whose tumours express a gene mutation called BRAF V600E.
