The CHMP ( Committee for Medicinal Products for Human Use ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Odomzo, 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 basal cell carcinoma.
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, blood creatine phosphokinase increased weight decrease and fatigue.
A pregnancy prevention plan and a pharmacovigilance plan for Odomzo will be implemented as part of the marketing authorisation.
The full indication is: Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma who are not amenable to curative surgery or radiation therapy. ( Xagena )
Source: European Medicines Agency ( EMA ), 2015