Celgene’s Revlimid (lenalidomide) has received a positive opinion from the European Commission for its use as a maintenance therapy for people with multiple myeloma who have already received an autologous stem cell transplant (ASCT).
The positive opinion was based on results from two key phase 3 trials.
The first trial, CALGB 100104, investigated the use of lenalidomide as a continuous daily treatment in 460 newly diagnosed multiple myeloma patients post-ASCT until relapse compared to placebo.
The second trial, IFM 2005-02, was similarly structured but had an initial two-month consolidation treatment period with lenalidomide assigned to a randomised patient group prior to daily treatment with the drug.
In both studies, the use of lenalidomide as a monotherapy post-ASCT significantly reduced the risk of disease progression or death.
“Despite substantial progress made so far in multiple myeloma treatment, it remains an incurable disease,” said Tuomo Pätsi, president of Celgene in Europe, the Middle East and Africa. “We welcome this CHMP opinion as it confirms the important role that Revlimid plays in treating multiple myeloma, extending the use of Revlimid across the disease continuum.”
Around 39,000 people are diagnosed with multiple myeloma every year in Europe, resulting in around 24,000 deaths.
The disease affects a class of immune cell called plasma cells. The role of plasma cells is to create structures called antibodies which are critical in protecting the body from infection or disease.
In multiple myeloma, diseased cells produce deformed antibodies which can lead to kidney problems and thickening of the blood.
Considered incurable, the typical treatment regimen for multiple myeloma patients under the age of 65 consists of induction therapy with high-dose chemotherapy before ASCT. The ultimate goal of the treatment is to extend the period of time before the disease progresses, however, over half of patients relapse within two to three years.
Revlimid has multiple mechanisms of action to combat cancer. The drug directly induces cancer cell death whilst preventing the formation of new blood vessels in tumours.
The drug’s multi-pronged approach has been exploited as a treatment for cancer since its introduction since 2004. However, much like the drug it’s derived from, thalidomide, there are concerns over the safety of the drug.
In both trials, the most common side effects associated with lenalidomide were neutropenia (an abnormally low number of a particular type of white blood cell), thrombocytopenia (low platelet count), infections, and an increased incidence of second primary tumours.