European Commission grants approval for Novartis' Odomzo in basal cell carcinoma
Swiss drug major Novartis (VX: NOVN) has received approval from the European Commission for Odomzo (sonidegib) for the treatment of locally advanced basal cell carcinoma (laBCC) in adult patients who are not amenable to curative surgery or radiation therapy.
The approval was based on data from the Phase II randomized, double-blind, multicenter BOLT study in patients with laBCC not amenable to local therapy, or metastatic basal cell carcinoma (mBCC). The response rate in laBCC patients treated with Odomzo 200mg, the objective response rate was 56% per central review and 71% per investigator review. The median duration of response per central review has not been reached. The median progression-free survival was 22 months per central review and 19 per investigator review.
The most frequent adverse reactions were fatigue, decreased weight and muscle spasms.
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