EU approves Odomzo (sonidegib, formerly LDE225) for locally advanced basal cell carcinoma- Novartis

The European Commission has approved Odomzo (sonidegib, formerly LDE225) 200 mg capsules, from Novartis, for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) who are not amenable to curative surgery or radiation therapy.

The EU approval was based on data from the Phase II randomized, double-blind, multi-center BOLT (Basal cell carcinoma Outcomes in LDE225 Trial) study in patients with laBCC not amenable to local therapy or metastatic basal cell carcinoma (mBCC). In patients with laBCC treated with Odomzo 200 mg, the objective response rate (ORR) was 56% by central review and 71% by investigator review. The median duration of response by central review has not been reached. The median progression-free survival was 22 months by central review and 19 months by investigator review. The most frequent grade 3 and 4 adverse reactions occurring in at least 2% of patients treated with Odomzo 200 mg were fatigue, decreased weight and muscle spasms.

Comment: Competition for Odomzo in this niche market 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 US and in the EU in 2013.