Novartis announced that the Food and Drug Administration (FDA) has approved Odomzo (sonidegib) capsules for the treatment of adults with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. 

The approval of Odomzo was based on results of the BOLT clinical trial, a Phase 2, international, multi-center, double-blind, randomized, two-arm, non-comparative trial that evaluated 230 patients with laBCC not amenable to local therapy or metastatic basal cell carcinoma (mBCC). Patients were randomized to receive Odomzo 800mg or 200mg daily until disease progression or unacceptable toxicity. The primary endpoint was the durable objective response rate (ORR) among patients with laBCC receiving Odomzo 800mg daily. 

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The ORR was 58% (95% CI: 45, 70), consisting of 5% (n=3) complete responses (CR) and 53% (n=35) partial responses (PR). A pre-specified sensitivity analysis using an alternative definition for CR resulted in a CR rate of 20%. Of the 38 patients with an objective response, 31 patients (82%) have ongoing responses ranging from at least 1.9–18.6 months; the median duration of response has not been reached.

Odomzo is an oral, selective smoothened (SMO) inhibitor that regulates the hedgehog (Hh) signaling pathway, which is critical in stem cell maintenance and tissue repair. 

Odomzo will be available in 200mg capsules in 30-count bottles.

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