publication date: Jul. 24, 2015
FDA Approved Odomzo in Basal Cell Carcinoma
FDA approved Odomzo (sonidegib) capsules for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Odomzo is marketed by Novartis Pharmaceuticals Corp.
The approval was based on demonstration of a durable objective response rate in an international, multi-center, double-blind, randomized, two-arm, non-comparative trial in patients with locally advanced basal cell carcinoma not amenable to local therapy or metastatic basal cell carcinoma.
The trial enrolled 230 patients who were randomized to receive Odomzo 800 mg (n=151) or 200 mg (n=79) daily until disease progression or unacceptable toxicity.
Randomization was stratified by disease stage (locally advanced or metastatic), histologic subtype (aggressive or nonaggressive) and geographic region. Eighty-four percent of those enrolled had locally advanced disease.
Approval was based on demonstration of durable objective responses in patients with laBCC as determined by central independent review according to a modification of RECIST. The ORR for the 66 patients with laBCC randomized to the Odomzo 200 mg arm was 58 percent (95% CI: 45, 70), consisting of three complete responses and 35 partial responses.
A pre-specified sensitivity analysis using an alternative definition for complete response, defined as at least a PR according to MRI and/or photography and no evidence of tumor on biopsy of the residual lesion, yielded a CR rate of 20 percent. A similar response rate was noted in the 128 patients with laBCC randomized to the Odomzo 800 mg arm [44 percent … Continue reading 41-29 FDA Approved Odomzo in Basal Cell Carcinoma
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