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FDA has approved a new indication for lenalidomide (Revlimid, Celgene) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
FDA has approved a new indication for lenalidomide (Revlimid, Celgene) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after 2 prior therapies, one of which included bortezomib.
According to Lymphomainfo.net, MCL accounts for about 1 in 20 non-Hodgkin’s lymphoma diagnoses in the United States.
“Revlimid in MCL represents a new option for patients who have exhausted typical lines of treatment,” said Greg Geissman, director of public relations, Celgene. “MCL has a very poor prognosis among non-Hodgkin’s lymphomas, and there is a significant need for treatment options once earlier lines of treatment fail.”
This represents the first oral therapy approved for this indication, providing patients with a convenient option for treatment.
The approval was based on the results of MCL-001, a phase 2, multicenter, single-arm, open-label study evaluating lenalidomide in 134 patients with MCL. Patients had received prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination.
Study patients had to have documented refractory disease during treatment or relapsed disease within 1 year after treatment with bortezomib or a bortezomib-containing regimen. Patients with a creatinine clearance rate ≥60mL/min were given lenalidomide at 25 mg once daily for 21 days every 28 days. Patients with a creatinine clearance ≥30mL/min and <60mL/min were given lenalidomide at a dose of 10 mg once daily for 21 days every 28 days.
The study primary end point was overall response rate based on a review of radiographic scans by an independent review committee according to a modified version of the International Workshop Lymphoma Response Criteria. More than 25% of study patients met the primary end point and 7% had a complete response.
Revlimid is an analogue of thalidomide and is contraindicated during pregnancy It is only available through Revlimid REMS, a restricted distribution program.