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FDA Approves Odomzo® (Sonidegib) for the Treatment of Locally Advanced Basal Cell Carcinoma
On July 24, 2015, the United States Food and Drug Administration (FDA) approved Odomzo (sonidegib) oral capsules for the treatment of adult patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or that is not amenable to curative surgery or radiation therapy. The recommended dose is 200 mg administered once daily under fasted conditions (i.e., at least one hour before or 2 hours after a meal).
Mechanism of Action (MOA), General Pharmacokinetics (PK) and Pharmacodynamics (PD) of Sonidegib
Drug Interaction Potential
Use in Specific Populations
No dose adjustment is recommended in patients with renal impairment or mild hepatic impairment. Mild hepatic impairment (defined as either total bilirubin less than or equal to the upper limit of normal (ULN) and aspartate aminotransferase (AST) greater than the ULN or total bilirubin greater than 1.0 to 1.5 times the ULN) or mild (creatinine clearance (CLcr) 60 to 89 mL/min) to moderate (CLcr 30 to 59 mL/min) renal impairment had no effect on sonidegib steady state exposure as compared to patients with normal organ function. The effect of moderate to severe hepatic impairment on sonidegib exposure is unknown.
Safety and Efficacy
The safety and effectiveness of Odomzo were evaluated in a single, randomized, placebo-controlled, double-blind, multiple cohort clinical trial conducted in 230 patients. The major efficacy outcome measure was objective response rate (ORR) and a supportive efficacy outcome measure was duration of response. In the 66 patients with locally advanced disease randomized to a 200 mg dose, the ORR was 58% (95% confidence interval: 45, 70). Among the 38 patients with an objective response, 7 (18%) patients experienced subsequent disease progression with 4 of these 7 patients having maintained a response of 6 months or longer. The remaining 31 patients (82%) had ongoing responses ranging from to 1.9+ to 18.6+ months. In the 79 patients treated with Odomzo 200 mg daily, the most common grade 3 or 4 adverse events were musculoskeletal, including elevation of serum creatine kinase, muscle spasms, musculoskeletal pain and myalgia, which occurred in 9% of patients.
Full prescribing information is available at http://go.usa.gov/3A4km.
The Office of Clinical Pharmacology (OCP) regulatory reviews for new drugs or biologics are often available for viewing shortly following approval at the Agency's Drugs@FDA website (http://go.usa.gov/3A48Y).
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This burst was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
FDA/Center for Drug Evaluation and Research (CDER)
Office of Translational Sciences
Office of Clinical Pharmacology
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