Odomzo (sonidegib)

Company: Sun Pharma

URL: www.odomzo.com

Indication: Locally advanced basal cell carcinoma. Approved 7/2015.

General Information

Odomzo is specifically indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

Mechanism of Action

Odomzo (sonidegib) is a hedgehog pathway inhibitor. Sonidegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction. 

Side Effects

Adverse effects associated with the use of Odomzo may include, but are not limited to, the following:

• Muscle spasms
• Alopecia
• Dysgeusia
• Fatigue
• Nausea
• Musculoskeletal pain
• Diarrhea
• Decreased weight
• Decreased appetite
• Myalgia
• Abdominal pain
• Headache
• Pain
• Vomiting
• Pruritus 

Dosing/Administration

Odomzo is supplied as a capsule for oral administration. The recommended dose is 200 mg orally once daily taken on an empty stomach, at least one hour before or two hours after a meal.

Clinical Trial Results

FDA Approval

The FDA approval of Odomzo was based on BOLT, a phase 2, randomized, double-blind multicenter trial. The primary end point was ORR of patients treated with Odomzo 200 mg and 800 mg, defined as the proportion of patients with confirmed complete or partial tumor response, or shrinkage, as measured by a central review committee. The ORR was 58 percent, consisting of 5 percent (n=3) complete responses (CR) and 53 percent (n=35) partial responses (PR). A prespecified sensitivity analysis using an alternative definition for CR, defined as at least a PR according to MRI and/or photography and no evidence of tumor on biopsy of residual lesion, yielded a CR rate of 20 percent. Among the 38 patients with an objective response, 31 patients (82 percent) have ongoing responses ranging from at least 1.9 to 18.6 months and the median duration of response had not been reached. There was no evidence of better ORR among patients with laBCC randomized to receive Odomzo 800 mg daily.