FDA Approves New Carcinoma Treatment

Sonidegib treats adult patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy.

The FDA today granted approval to a new treatment option for adults with a disfiguring form of skin cancer.

Sonidegib (Odomzo) is administered as a 200 mg capsule for adult patients with locally advanced basal cell carcinoma (laBCC) that recurred after surgery or radiation therapy, or for patients who are not candidates for surgery or radiation treatment.

"The FDA approval of Odomzo offers a new and non-invasive treatment option for a potentially devastating disease that is hard to treat and can be disfiguring," said Bruno Strigini, president of Novartis Oncology. "Odomzo is an important addition to our growing portfolio of targeted treatments for advanced skin cancers and underscores our commitment to developing and bringing to market new options for patients."

The approval of sonidegib followed an international, multi-center, double-blind, randomized, two-arm, non-comparative trial in patients with laBCC who were not amenable to local therapy or metastatic basal cell carcinoma.

Patients treated with Odomzo 200 mg were followed for at least 12 months unless treatment was discontinued earlier. The durable objective response rate (ORR) was 58% (95% confidence interval: 45, 70), comprised of 5% (n=3) complete responses and 53% (n=35) partial responses.

Among 38 patients with an objective response, 31 (82%) registered ongoing responses from at least 1.9 to 18.6 months.

The most serious risks from sonidegib were embryofetal toxicity and musculoskeletal adverse reactions, including rhabdomyolysis. Musculoskeletal adverse reaction incidence in patients treated with Odomzo 200 mg was 68%, with 9% reported as grade 3 or 4.

The most common adverse events reported in more than 10% of patients treated with sonidegib included muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, and pruritus.