The FDA gave its coveted nod to Erivedge for the treatment of basal cell carcinoma (BCC).
Made by Genentech, a unit of Swiss drugmaker Roche, Erivedge (vismodegib) is approved to treat locally advanced BCC among patients who are not candidates for surgery or radiation. It is also indicated for patients whose cancer has metastasized. Taken by capsule once per day, Erivedge is a first-in-class Hedgehog Pathway Inhibitor. This pathway plays an important role in regulating proper cell growth and development in the early stages of life and becomes less active in adults. Abnormal Hedgehog signaling is implicated in more than 90% of BCC cases.
The new pill will be available within one to two weeks. The approval comes ahead of schedule. The FDA previously said it would make a decision on by March 8, 2012. Erivedge was given a fast 6-month review because there are no other approved treatments for BCC.
Erivedge should not be taken by pregnant women. Common side include: muscle spasms, hair loss, weight loss, diarrhea, fatigue, changes or loss in sense of taste, decreased appetite, constipation, and vomiting.
For more information about Erivedge, go to http://www.Erivedge.com