Odomzo (sonidegib)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

July 2015

Specific Treatments:

locally advanced basal cell carcinoma

Therapeutic Areas

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General Information

Odomzo (sonidegib) is a hedgehog pathway inhibitor.

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.

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 1 hour before or 2 hours after a meal.

Clinical Results

FDA Approval

The FDA approval of Odomzo was based on BOLT, a phase II, randomized, double-blind multicenter trial. The primary endpoint 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%, 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, 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%.1 Among the 38 patients with an objective response, 31 patients (82%) 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.

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 

Mechanism of Action

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

Additional Information

For additional information regarding Odomzo, or basal cell carcinoma, please visit http://odomzo.com/