Revlimid, from Celgene, wins new indication approval for mantle cell lymphoma by the FDA

June 6, 2013 | By Márcio Barra

Revlimid, Celgene’s best-selling drug ($3.8 billion), won a line extension approval by the FDA for patients with a rare and aggressive form of cancer called mantle cell lymphoma in white blood cells, in patients whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (a proteasome inhibitor for treating relapsed multiple myeloma and mantle cell lymphoma, sold under the name Velcade, by Johnson & Johnson and Takeda).

Revlimid (Lenalidomide), is an oral analogue of thalidomide approved back in 2005 for multiple myeloma, another white blood cell cancer, that significantly improved overall survival in multiple myeloma. Lenalidomide use is hindered by its neurotoxicity, with up to 75% of patients discontinuing maintenance therapy with Lenalidomide.

The approval was based on the results of MCL-001, a phase II study evaluating lenalidomide in 134 patients with mantle cell lymphoma who had received prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib, alone or in combination. This makes Revlimid the first oral therapy for mantle cell lymphoma approved.

Mantle cell lymphoma is a type of non-Hodgkin’s lymphoma that is very rare. Few treatments for the disease are available. Dr. Andre Goy with the Hackensack University Medical Center says that “there remains a tremendous unmet need” for patients who have not responded satisfactorily after previous treatments.

The drug is expected to hit $5.9 billion in sales in 2016, according to estimates compiled by Bloomberg. While this approval is positive news for Celgene, the biotech presented some not so positive results earlier this week at the American Society of Clinical Oncology – ASCO – from a phase 3 study of a Revlimid combined with melphalan and prednisone in treating newly diagnosed multiple myeloma. The data showed that patients taking this combination had lower median progression-free survival and overall survival rates than patients taking a high-dose chemotherapy and a tandem autologous stem cell transplant regimen called MEL200. Fortunately for Celgene, the study also showed that patients taking Revlimid as a maintenance therapy for either regimen showed higher median progression-free and overall survival rates.



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