Sanofi’s Rezurock (belumosudil) will be fast-tracked by the NHS as a treatment for cancer patients living with chronic graft versus host disease (cGVHD).
For the next three years, provided by funding from the Innovation Medicines Fund, around 200 patients are set to benefit from Rezurock.
Affecting around a third of patients who have undergone stem cell or bone marrow transplants for blood cancers including leukaemia and lymphoma, cGVHD is a serious complication that occurs when white blood cells in donated tissue begin to attack recipients’ organs, weakening their immune system.
In England, around 400 of 1,200 patients who have undergone a stem cell or bone marrow transplant will develop the disease each year, making patients more vulnerable to infections, 50% of whom will not respond to currently available treatments including pentostatin, rituximab and imatinib.
Following guidance from the National Institute of Health and Care Excellence (NICE) in December last year, patients living with the most severe cases of the disease aged 12 years and older who have not had success with two prior therapies are set to benefit from Rezurock.
NICE’s decision was based on results from the phase 2 ROCKstar trial, which showed that 75% of 132 patients with cGVHD aged 12 years or older receiving Rezurock achieved a response in all organs within a year of treatment.
Additionally, seven patients in the modified intent-to-treat population showed a complete response in all affected organs.
Taken as a tablet once a day, Rezurock works to inhibit the proteins responsible for the inflammatory response caused by cGVHD.
James Palmer, medical director for specialised services, NHS England, commented: “This rollout… will help people living with this debilitating condition [to] effectively manage their symptoms and enhance their quality of life and daily functioning.”
In 2019, the therapy was granted orphan drug designation by the Medicines and Healthcare products Regulatory Agency and the European Commission to treat cGVHD.
More recently, Rezurock was approved by the US Food and Drug Administration in 2021 for the treatment of adults and paediatric patients aged 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy.
