Posted on July 12th, 2013 by
The U.S. Food and Drug Administration (FDA) has approved Revlimid® (lenalidomide) for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included Velcade® (bortezomib).
Non-Hodgkin’s lymphoma (NHL) is a form of cancer that begins in the cells of the lymph system. It is characterized by the excessive accumulation of atypical (cancerous) lymphocytes. These lymphocytes can crowd the lymph system and suppress the formation and function of other immune and blood cells. Mantle cell lymphoma is a subset of NHL that accounts for approximately 5%–10% of all lymphomas.
Revlimid is an oral medication that can stop or slow the growth of cancerous cells within the bone marrow. It has historically been used in the treatment of multiple myeloma. The new approval was based on the results of a single-arm, multi-center clinical trial that included 134 patients with mantle cell lymphoma who had relapsed after or were refractory to Velcade or a Velcade-containing regimen. All patients received prior treatment with Velcade and 60 percent were documented to have disease that was resistant to Velcade.
The study evaluated overall response rate (ORR) and duration of response (DOR). The ORR was defined as the proportion of patients whose best response was complete response (CR), complete response unconfirmed (CRu), or partial response (PR). The results indicated that the ORR was 26 percent and CR or CRu was achieved by 7 percent of patients. Nineteen percent of patients achieved a partial response (PR). The median DOR for patients who achieved a CR, CRu, or PR was 16.6 months.
All patients received at least one dose of Revlimid and 58 percent of patients received three or more cycles of the drug. Fifty-seven percent of patients experienced at least one dose interruption due to adverse events and 38 percent had at least one dose reduction due to adverse events. Nineteen percent of patients discontinued treatment due to adverse events.
The most common grade 1-4 adverse reactions included neutropenia, thrombocytopenia, fatigue, anemia, diarrhea, nausea, cough, pyrexia, rash, dyspnea, pruritis, constipation, peripheral edema and leukopenia. The most common grade 3-4 adverse reactions were neutropenia, thrombocytopenia, anemia, pneumonia, leukopenia, fatigue, febrile neutropenia, dyspnea and diarrhea.
Lenalidomide [FDA Announcement]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm355438.htm
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