The U.K. National Institute for Health and Care Excellence expanded the approval of Celgene Corp.'s Revlimid, making it eligible for use as a treatment in the first-line setting.
NICE recommended a combination of Revlimid, or lenalidomide, and dexamethasone for previously untreated patients with multiple myeloma. The drug regimen is approved for patients who are not eligible for a stem cell transplant and cannot take thalidomide.
Thalidomide is used as the first treatment for multiple myeloma, but it can cause side effects including bruising, breathlessness and increased risk of infection. Multiple myeloma is blood cancer that forms in plasma cells — a type of white blood cells — that are responsible for producing antibodies. It is characterized by a recurring pattern of remission and relapse.
The U.K. price watchdog also recommended Revlimid for adults with multiple myeloma that have previously received only one therapy, which includes bortezomib. Patients under the National Health Service have the option of chemotherapy as a second treatment, while Revlimid is the third-line option.
Results from clinical studies have shown that Celgene's Revlimid in combination with dexamethasone increases the length of time patients live by seven months on average compared to bortezomib-based therapy.
The decision will give 2,100 patients an option to choose a combination of Revlimid and dexamethasone as their first treatment, while another 320 patients will benefit from it as a second-line treatment. NICE also noted that recommendation of Revlimid as a first treatment will reduce the need for it as a second-line option.
England's National Health Service said it has a deal with Celgene under which the company provides Revlimid for an undisclosed discounted price.