Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Roche's new drug application (NDA) for vismodegib has been accepted by the US Food and Drug Administration (FDA).
Subscribe to our email newsletter
Vismodegib is an investigational, oral, targeted medicine which selectively inhibits signaling in the Hedgehog pathway and treats adults with advanced basal cell carcinoma (BCC).
The vismodegib application includes Erivance BCC study primary endpoint results which showed vismodegib substantially shrank tumours or healed visible lesions (objective response rate, or ORR) in 43% of patients with locally advanced BCC (laBCC) and 30% of patients with metastatic BCC (mBCC).
The ORR as assessed by study investigators, a secondary endpoint, was 60% for laBCC and 46% for mBCC.
The median progression-free survival (PFS) by independent review for both metastatic and locally advanced BCC patients was 9.5 months.
Roche Global Product Development CMO and head Hal Barron said they are pleased the FDA has granted priority review for vismodegib and they look forward to work with the Agency on the review of the data.