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news.Bristol-Myers Squibb's Opdivo has been recommended by the European Medicines Agency (EMA) for use in the treatment of adult patients with advanced melanoma in the European Union (EU).
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The suggestion for granting a marketing authorisation for the drug is based on the positive results obtained from two main studies in patients with advanced malignant melanoma.
During the first study, 418 melanoma patients, who had not received previous treatment for their melanoma, were randomly assigned to receive either Opdivo or standard chemotherapy (dacarbazine).
The survival rate of patients treated with Opdivo was 73%, while patients who received dacarbazine reported survival rate of 42% after one year.
Featuring 405 patients who had received previous treatment for their melanoma and were randomised to receive Opdivo or chemotherapy, such as dacarbazine or carboplatin and paclitaxel, the second study found that 31.7% of patients responded to Opdivo compared with chemotherapy, with 10.6%.
A follow-up plan to monitor the safety and efficacy of Opdivo was agreed by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Bristol-Myers Squibb Oncology development head and senior vice-president Michael Giordano said: "We are pleased with today’s CHMP positive opinion, as it is a step closer to us bringing this important medicine for those advanced melanoma patients in Europe in need of new options."
Also called nivolumab, Opdivo is claimed to be the first cancer treatment selectively targeting the programmed death-1 (PD-1), a receptor which plays a significant role in down regulating the immune system.
The drug attaches to and blocks PD-1, which blocks the usual receptor interactions and leads to activation of the immune system to kill melanoma cells.
The CHMP opinion is now scheduled to be sent to the European Commission for the adoption of a decision on EU-wide marketing authorisation.
Following receipt of marketing authorisation, a decision about price and reimbursement will take place at the level of each EU member state considering the potential role/use of the medicine in the context of the national health system of that country.
Melanoma is claimed to be the most aggressive type of skin cancer and the leading cause of death from skin disease.
Image: The European Medicines Agency has recommended Opdivo’s use for the treatment of adult patients with advanced melanoma, seen here on a patient’s skin. Photo: courtesy of Unknown.