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Search results for sonidegib in LACTMED (approximate match)
Showing 1 - 1 of 1 results
Status:
US Approved Rx
(2015)
Source:
NDA205266
(2015)
Source URL:
First approved in 2015
Source:
NDA205266
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Sonidegib, also known as LDE225 and marketed as Odomzo, is a Hedgehog signaling pathway inhibitor (via smoothened antagonism) developed as an anticancer agent by Novartis. It was approved by the FDA for treating basal cell carcinoma in July 2015 and is awaiting approval in the EU. The hedgehog pathway is involved in many human cancers. Sonidegib effectively inhibits the regulator called smoothened (Smo), preventing the hedgehog pathway from functioning. As a result, tumours that depend on the hedgehog pathway are unable to grow. Sonidegib is approved for use in the US and EU for treatment of adults with locally advanced basal cell carcinoma (BCC) that has recurred post surgery or radiation therapy. It is also approved for adult patients with BCC who are not eligible for surgery or radiation therapy.