A branch of the European Medicines Agency voiced support for Revlimid (lenalidomide) in combination with rituximab becoming a treatment option for adults with follicular lymphoma who responded poorly to, or whose disease returned after, prior therapy.
The Committee for Medicinal Products for Human Use (CHMP), an advisory committee for the EU’s regulatory agency, recommended the combo’s approval. CHMP reviews applications for all EU member states, as well as Norway, Liechtenstein, and Iceland.
If favored by the European Commission, this combo will become the first chemotherapy-free regimen available for follicular lymphoma patients in Europe. A final decision is expected in about two months.
The U.S. Food and Drug Administration (FDA) approved the combination for follicular lymphoma and marginal zone lymphoma (MZL) in May, three months after granting priority review to the application submitted by Celgene, which markets Revlimid. (Celgene is now part of Bristol-Myers Squibb.)
“Since its initial approval in 2007, Revlimid has continued to demonstrate its benefits across a range of serious blood disorders in Europe and a CHMP positive opinion for this combination with rituximab is very good news for patients with follicular lymphoma. We look forward to the European Commission decision,” Tuomo Pätsi, president of Hematology/Oncology for Celgene Worldwide Markets, said in a press release.
Follicular lymphoma is the most common form of indolent, or slow-growing, non-Hodgkin’s lymphoma (NHL), accounting for 25% of all NHL patients. NHL incidence in Europe was estimated at 100,055 cases in 2018 alone.
Although follicular lymphoma patients usually respond to initial treatment, the disease typically keeps coming back, with shorter remission periods (times when few or no signs of the disease are evident) at each relapse.
Given its incurable nature, new treatments are needed to both extend patient lives and prevent their cancer from progressing, especially in those who have been treated previously.
“Chemotherapy is a standard of care for indolent forms of NHL, but most patients will relapse or become refractory to their current treatment,” said John Gribben, MD, president of the European Hematology Association (EHA) and Centre for Haemato-Oncology, Barts Cancer Institute.
“The combination of Revlimid and rituximab could represent a new, chemotherapy-free treatment option for patients with previously treated follicular lymphoma,” he added.
CHMP based its positive recommendation on the results from the AUGMENT Phase 3 trial (NCT01938001), which evaluated the efficacy and safety of Revlimid-rituximab versus rituximab plus placebo in 295 previously treated follicular lymphoma patients (grade 1, 2 or 3a).
Results showed that patients given the combination lived significantly longer without disease progression (median 39.4 months) compared to rituximab plus placebo (14.1 months). This 25-month extension represented a 54% reduction in the risk of disease progression or death.
More patients also responded to the combo than to rituximab alone (78% vs. 53%), and patients achieved a complete response (34% vs. 18%), meaning they were free of any signs of disease.
Findings from the MAGNIFY Phase 3b trial (NCT01996865) were included to support the combo’s safety and efficacy in patients with relapsed (returned) or refractory (resistant to treatment) follicular lymphoma, including those who did not respond to rituximab.
Rituximab (marketed under the brand names Rituxan and Truxima) is a monoclonal antibody that targets B lymphocytes, or B-cells, the immune cells that cause follicular lymphoma. The agent specifically binds to immature and mature B-lymphocytes, triggering their death. It is given by injection into a vein.
Revlimid is an immunomodulator that works by boosting the immune system’s ability to find and destroy tumor cells. It stimulates an increase in the numbers and activation of immune T and natural killer (NK) cells, enhancing the killing of tumor cells. It is available as oral capsules.
As Revlimid and rituximab have complementary mechanisms of action, combining the two is believed to increase the activation of anti-tumor immunity and induce greater tumor cell death.
Both medicines are approved, alone or in combination, to treat other blood cancer types (among other uses) in countries worldwide, including in the U.S. and Europe.
