Bristol-Myers Squibb's Opdivo approved to treat blood cancer in EU
Bristol-Myers Squibb's drug Opdivo (nivolumab) has been approved for use in the European Union (EU) to treat classical Hodgkin lymphoma (cHL), a type of blood cancer.
Hodgkin lymphoma is a cancer that affects lymphatic vessels and glands throughout the body. It attacks B-lymphocyte cells and triggers their abnormal multiplication.
The approval is specific for patients whose cancer has relapsed or is refractory even after autologous stem-cell transplantation and treatment with brentuximab vedotin.
Bristol-Myers Squibb UK and Ireland general manager Benjamin Hickey said: “We are delighted that nivolumab has been approved across Europe for the treatment of classical Hodgkin lymphoma. Patients with the potential to benefit are those who have failed standard therapies and have no alternative options.
“The approval comes at a time when pivotal new data presented at ASH are demonstrating the potential this treatment can offer to patients with this type of blood cancer.
“We are fully committed to working with reimbursement authorities to ensure that all eligible patients in the UK are able to benefit from this treatment as quickly as possible.”
The approval follows the presentation of new data at the American Society for Hematology congress, which indicates that about 95% of patients in this setting, were still alive at one year.
According to the primary endpoint of the study objective response rate, a considerable cancer reduction was observed in more than two-thirds of patients on nivolumab (68%, 95% CI: 56%, 78%).
As well as 8% (95% CI: 3%, 16%) of these patients experienced a complete response without any remnant sign of cancer.
Previously reported data was consistent with the safety profile of nivolumab in this setting.
Earlier this year, the Early Access to Medicines Scheme for cHL has approved nivolumab's use in this setting.
For access through National Health Service (NHS) in UK, the drug has to undergo a review by the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC).
The drug is being currently reviewed by NICE for NHS patients in England and Wales with advanced lung cancer.