EU regulators have issued a green light for the use of Bristol-Myers Squibb's Opdivo to treat the rare and often aggressive blood cancer classical Hodgkin lymphoma (cHL).
The decision means that doctors can prescribe the immunotherapy for patients whose cancer is progressing (relapsed or refractory) despite autologous stem cell transplantation (ASCT) and treatment with brentuximab vedotin (BV).
"This is a significant step forward for Hodgkin lymphoma patients," said Dr Graham Collins, Consultant Haematologist, Oxford University Hospitals Foundation Trust. "Historically, once a patient's cancer progresses to this stage they are generally placed on palliative end-of-life care. The launch of nivolumab changes the treatment landscape, offering an innovative approach to treating this cancer."
The approval comes as new data from the Checkmate 205 trial presented at the American Society for Hematology (ASH) congress show that nearly 95 percent of patients were still alive at one year, and that "considerable cancer reduction" was seen in over two-thirds of patients on Opdivo (68 percent), with a complete response observed in 8 percent.
Other data from the trial demonstrated 12-month progression-free survival (PFS) in over half of patients (54.6 percent) with the median duration of response lasting for over a year. On the safety side, Grade 3/4 drug-related adverse events occurred in 29 percent of patients, the most common of which were increased lipase (8 percent), neutropaenia (5 percent), and increased aspartate aminotransferase (4 percent), the firm noted.
Nearly 2,000 people are diagnosed with cHL in the UK each year, mostly adults in their 20s and 30s.
Opdivo has already been available to cHL patients in the UK through the country's Early Access to Medicines Scheme; it will now undergo a review by the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) to determine whether access will be routinely granted through the NHS.
"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," noted Benjamin Hickey, general manager, UK and Ireland, BMS.
Opdivo is a PD-1 immune checkpoint inhibitor, already approved in Europe for the treatment of advanced melanoma, metastatic squamous and non-squamous non-small cell lung cancer, kidney cancer and previously-treated recurrent or metastatic squamous cell carcinoma of the head and neck.