The European Medicines Agency (EMA) has recommended approval for Opdivo (nivolumab). Opdivo is indicated for treatment of adult patients with advanced (unresectable or metastatic) melanoma.
Melanoma, the most serious type of skin cancer, develops in the cells (melanocytes) that produce melanin the pigment that gives your skin its color. Melanoma can also form in your eyes and, rarely, in internal organs, such as your intestines. The exact cause of all melanomas isn't clear, but exposure to ultraviolet (UV) radiation from sunlight or tanning lamps and beds increases your risk of developing melanoma. Limiting your exposure to UV radiation can help reduce your risk of melanoma.If melanoma is detected early, it can often be removed by surgery (resected) and has a very good prognosis. For decades, chemotherapy was the standard treatment for patients with advanced melanoma, but it did not improve survival.
The active substance in Opdivo (nivolumab) is a monoclonal antibody. Nivolumab attaches to and blocks a receptor called ‘programmed death-1’ (PD-1). By arresting the usual receptor interactions, Opdivo leads to activation of the immune system to kill melanoma cells. Opdivo is the first cancer treatment selectively targeting PD-1 recommended for approval in the European Union (EU).
Opdivo’s recommendation is based on two main studies in patients with advanced malignant melanoma. The first study randomly assigned 418 patients who had not received previous treatment for their melanoma, to receive either Opdivo or standard chemotherapy (dacarbazine). After 12 months, the survival rate of patients treated with Opdivo was much higher than the rate of patients who received dacarbazine (73% compared with 42%). The second study randomised 405 patients who had received previous treatment for their melanoma to receive Opdivo or chemotherapy (either dacarbazine or carboplatin and paclitaxel) and found that a greater proportion of patients responded to Opdivo compared with chemotherapy (31.7% compared with 10.6%). A follow-up plan to monitor the safety and efficacy of Opdivo was agreed by the Committee for Medicinal Products for Human Use (CHMP).
The opinion adopted by the CHMP at its April 2015 meeting is an intermediary step on Opdivo’s path to patient access. The CHMP opinion will now be forward to the European Commission for decision on EU-wide marketing authorisation. Once amarketing authorisation has been granted, a price and reimbursement will be fixed at the level of each Member State considering the potential role/use of this medicine in the context of the national health system of that country. The applicant for Opdivo is Bristol-Myers Squibb Pharma EEIG.
Subscribe to PharmaTutor News Alerts by Email >>
.png)
