U.S. Food and Drug Administration Approves REVLIMID® (lenalidomide) for the Treatment of Patients with Relapsed or …

SUMMIT, N.J.--(BUSINESS WIRE)--

Celgene Corporation (CELG) today announced the U.S. Food and Drug Administration (FDA) has approved the companys 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, M.D., M.S., 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

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-fetal 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. Tumor lysis syndromes, including fatalities, have been reported during treatment with REVLIMID. Serious tumor flare reactions have occurred during investigational use of REVLIMID for chronic lymphocytic leukemia 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%), anemia (11%), pneumonia (9%), fatigue (7%), leukopenia (7%), febrile neutropenia (6%), diarrhea (6%), and dyspnea (6%).

REVLIMID(lenalidomide) is indicated 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.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS THROMBOEMBOLISM

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U.S. Food and Drug Administration Approves REVLIMID® (lenalidomide) for the Treatment of Patients with Relapsed or ...