CHMP recommends Odomzo (sonidegib) to treat basal cell carcinoma- Novartis
On 25 June 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Odomzo (sonidegib) from Novartis, intended for the treatment of adults with locally-advanced basal cell carcinoma (BCC). Odomzo will be available as 200 mg hard capsules. The active substance of Odomzo is sonidegib, an antineoplastic agent.
Sonidegib inhibits the Hedgehog pathway, a key regulator of development and morphogenesis in mammals, which is linked to the pathogenesis of several cancers including BCC. The benefits with Odomzo are its ability to reduce locally advanced BCC lesions, with a response rate of about 54% and a progression-free survival of approximately 22 months. The most common side effects of Odomzo treatment are muscle cramps, muscle pain, hair loss, alteration or loss of taste, nausea, diarrhoea, increased blood creatine phosphokinase, weight loss and fatigue.
Comment: Competition for Odomzo will come from Hedgehog inhibitor Erivedge (vismodegib), licensed from Curis and marketed by Roche, which was approved to treat basal cell carcinoma in 2012 in the USA and in the EU in 2013.
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