Novartis receives EU approval for Odomzo

Novartis has been granted European regulatory approval for Odomzo, its new treatment for advanced basal cell carcinoma.

The European Commission has approved the non-invasive sonidegib-based therapy for the treatment of advanced basal cell carcinoma patients who are not amenable to curative surgery or radiation therapy.

Pivotal phase II clinical trial data showed a durable objective response rate per central review among 56 percent of patients, earning it a recommendation from the European Medicine Agency's Committee for Medicinal Products for Human Use in June.

Basal cell carcinoma is the most common form of skin cancer and can be highly disfiguring and invasive at advanced stages.

Bruno Strigini, president of Novartis Oncology, said: "This milestone follows the recent approval of Odomzo in the US and is the latest example of our commitment to precision oncology and developing targeted treatments to address unmet needs."

Last month, the company received a recommendation for EU approval of a new combination of Tafinlar and Mekinist in the treatment of adult patients with unresectable or metastatic melanoma.