Revlimid Receives New Lymphoma Indication
May 28, 2019 – The U.S. FDA has approved a new indication for Revlimid® (lenalidomide), manufactured by Celgene. It is now approved for use in combination with a rituximab product as a treatment for adult patients who have previously treated follicular lymphoma or marginal zone lymphoma. This is the first non-chemotherapy combination to receive FDA approval to treat these cancers.
Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are indolent forms of non-Hodgkin’s lymphoma (NHL), meaning that they grow slowly. Approximately 20% of all NHL cases are FL cases, while MZL accounts for an estimated 8% of NHL diagnoses. While indolent forms of NHL can be highly treatable, disease may return months or years after a patient completes treatment, requiring further therapy.
In a clinical study, patients treated with Revlimid and rituximab achieved a median progression-free survival time of 39.4 months compared to 14.1 months for patients who received rituximab (a current standard of care for NHL) and a placebo. There were also fewer deaths recorded in the patient group that received the Revlimid and rituximab combination: 16 with Revlimid and rituximab versus 26 with rituximab and placebo.
Recommended dosing under the new indication is 20mg of Revlimid taken by mouth once each day for 21 days followed by one week off Revlimid, for up to 12 cycles or until unacceptable toxicity in combination with a rituximab-product.
A black box warning cautions that Revlimid carries a risk of embryo-fetal toxicity, hematologic (blood) toxicity, and venous and arterial thromboembolism (blood clots in veins and arteries). Rituximab carries a black box warning that it may cause fatal infusion-related reactions, severe mucocutaneous (skin and mucous membrane) reactions, hepatitis B virus reactivation (in patients infected with the virus), and multifocal leukoencephalopathy.
First FDA approved in 2005, Revlimid is also indicated to treat multiple myeloma, mantle cell lymphoma, and certain forms of transfusion-dependent anemia. Rituximab first received FDA approval in 1997, and is indicated to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s granulomatosis, microscopic polyangiitis, and pemphigus vulgaris.