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Published on 6 June 2013

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US FDA approves REVLIMID

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Celgene Corporation (NASDAQ: CELG) has announced the US Food and Drug Administration (FDA) has approved the company’s supplemental new drug application (sNDA) for REVLIMID® (lenalidomide) 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.
“There remains a tremendous unmet need for patients with previously-treated mantle cell lymphoma,” said Andre Goy MD MS, Chairman and Director and Chief of Lymphoma, John Theurer Cancer Center at Hackensack UMC and Chief Science Officer and Director of Research and Innovation at Regional Cancer Care Associates, LLC. “The approval of lenalidomide delivers a new option, and the first oral therapy in this area of lymphoma.
The approval was based on the results of MCL-001, a phase II, multi-center, single arm, open label study evaluating lenalidomide in 134 patients with MCL who had received prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination. Patients were required to have documented refractory disease (defined as without any response of partial response or better during treatment with bortezomib or a bortezomib-containing regimen), or relapsed disease (defined as progression within one year after treatment with bortezomib or a bortezomib-containing regimen). Patients with a creatinine clearance ≥60mL/min were given lenalidomide at 25mg 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 10mg once daily for 21 days every 28 days.
In the study, the primary endpoint – 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 – was 26% (34/133) (95% CI 18.4, 33.9) with a complete response rate (CR/CRu) of 7% (9/133) (95% CI 3.1, 12.5). The median duration of response was 16.6 months (95% CI, 7.7, 26.7).
REVLIMID is an analogue of thalidomide, is contraindicated in pregnancy, and if used during pregnancy may cause birth defects or embryo-foetal death. It is only available through a restricted distribution program called REVLIMID REMS™. Revlimid can cause significant neutropenia and thrombocytopenia. Deep venous thrombosis (DVT) and pulmonary embolism (PE) occur in patients who have been treated with REVLIMID. Allergic reactions, including fatalities, comprising hypersensitivity, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis have been reported in patients treated with REVLIMID.
Tumour lysis syndromes, including fatalities, have been reported during treatment with REVLIMID. Serious tumour flare reactions have occurred during investigational use of REVLIMID for chronic lymphocytic leukaemia and lymphoma. Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID in combination with dexamethasone.
Higher incidences of second primary malignancy were observed in controlled trials of patients with multiple myeloma receiving REVLIMID. Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.
The most common grade 3/4 adverse reactions reported in ≥5% of patients were neutropenia (43%), thrombocytopenia (28%), anaemia (11%), pneumonia (9%), fatigue (7%), leukopenia (7%), febrile neutropenia (6%), diarrhoea (6%), and dyspnea (6%).


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