European regulators have expanded the scope of Bristol-Myers Squibb's immunotherapy Opdivo, approving its use to treat certain patients with Classical Hodgkin Lymphoma (cHL).
Marking its sixth approval across four distinct cancer types, Opdivo (nivolumab) can now be used to treat adults patients with relapsed or refractory forms of the disease following autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
Approval was based on an integrated analysis of data from the Phase II CheckMate -205 and the Phase I CheckMate -039 trials, which showed an objective response rate of 66 percent, including a complete response rate of six percent. At 12 months, the progression-free survival rate was 57 percent.
"We now have an entirely new treatment approach that has shown impressive response rates and durability of response in this difficult-to-treat population," said Andreas Engert, lead investigator and professor of Internal Medicine, Haematology and Oncology, University Hospital of Cologne, Cologne, Germany, commenting on the drug's clearance.
Opdivo is now the first and only PD-1 inhibitor approved for a haematologic malignancy in the European Union.
The drug is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to uniquely harness the body's own immune system to help restore anti-tumor immune response, also approved in Europe for non-small cell lung cancer, melanoma and kidney cancer.
Just weeks ago it was announced that the drug would be available to cHL patients in the UK ahead of its European licence for the indication through the country's Early Access to Medicines Scheme.
Nearly 2,000 people are diagnosed with cHL in the UK each year, mostly adults in their 20s and 30s.