Odomzo gains approval to treat laBCC

Novartis drug Odomzo gains approval for locally advanced basal cell carcinoma, providing non-invasive therapy for patients

Novartis has gained approval from the European Commission (CE) for Odomzo (sonidegib, formerly LDE225) 200mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC).

Basal cell carcinoma (BCC) consists of abnormal, uncontrolled growths or lesions that arise in the skin's basal cells, which line the deepest layer of the epidermis and accounts for more than 80% of non-melanoma skin cancers.

Worldwide incidence of BCC is rising by 10% each year due to factors such as an aging population and increased ultraviolet exposure.

Reinhard Dummer, professor and vice chairman, department of dermatology at the University of Zurich, said: "I have seen first-hand the devastating impact advanced basal cell carcinoma can have on those living with the disease

"The approval of Odomzo brings new hope in the form of a non-invasive option to help treat this disfiguring and potentially life-threatening disease."

The EU approval of Odomzo was based on data from the Phase II randomised, double-blind, multi-centre Basal cell carcinoma Outcomes in LDE225 Trial (BOLT) study in patients with laBCC not amenable to local therapy or metastatic basal cell carcinoma (mBCC).

In patients with laBCC treated with Odomzo 200mg, the objective response rate was 56% per central review and 71% per investigator review.

Bruno Strigini, president, Novartis Oncology, said: "We are pleased to have a new treatment option for European patients living with advanced basal cell carcinoma.”

The approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in June 2015 and applies to all 28 EU member states plus Iceland, Norway and Liechtenstein.

Outside the EU, Odomzo is approved in the United States, Australia and Switzerland.