Monday, January 30, 2012

FDA approves Vismodegib - First ever drug for inoperable basal cell carcinoma

The drug has been approved ahead of  the PDUFA , scheduled for March 8 2012.  Vismodegib is a once daily oral pill and works by inhibiting the Hedgehog pathway.

In the pivotal ERIVANCE BCC study, vismodegib substantially shrank tumors or healed visible lesions showing an objective response rate in 43% of patients with locally advanced BCC and 30% of patients with metastatic BCC (mBCC),based on an independent investigation.