FDA Grants VELCADE(R) (bortezomib) for Injection Fast Track Status for Relapsed and Refractory Mantle Cell Lymphoma
Tuesday November 2, 4:15 pm ET
-- Phase II mantle cell lymphoma development an integral component of Company's broad NHL program --
CAMBRIDGE, Mass., Nov. 2 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the Food and Drug Administration (FDA) has granted VELCADE fast track designation for relapsed and refractory mantle cell lymphoma, an aggressive form of non-Hodgkin's lymphoma (NHL) which accounts for approximately six percent of all lymphomas. Currently, VELCADE is being evaluated as a single agent in a Company-sponsored multicenter Phase II clinical trial for the treatment of mantle cell lymphoma in addition to multiple investigator-initiated trials. These trials are part of an ongoing research collaboration between Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. to jointly investigate VELCADE in hematologic and solid tumors. VELCADE is currently indicated for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy.
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"We are pleased that the FDA has recognized the unmet medical need of patients suffering from mantle cell lymphoma," said David Schenkein, M.D., vice president, clinical oncology development, Millennium. "Mantle cell lymphoma remains one of the deadliest forms of cancer and is generally considered incurable. Millennium remains committed to the clinical development and registration of VELCADE as a treatment for the critical unmet medical needs of patients suffering from mantle cell lymphoma."
Under the FDA Modernization Act of 1997, designation as a fast track product indicates that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious life- threatening condition, and demonstrates the potential to address unmet medical needs for such a condition. Specifically, this designation allows for the FDA to accept on a rolling basis portions of a marketing application for review prior to the completion of a final document.
The fast track designation is based on preliminary data from an ongoing Company-sponsored phase II clinical trial of VELCADE in patients with relapsed or refractory mantle cell lymphoma, and the commitment to a full development program designed to lead to registration. The trial, initiated in June 2003, is designed to assess time to progression, response rate, duration of response and overall survival in patients with relapsed or refractory mantle cell lymphoma following one or two prior chemotherapeutic regimens. Millennium anticipates interim data will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2005.
Support of this designation was based on data from four separate Phase II investigator-initiated studies of VELCADE as a single agent for the treatment of indolent and aggressive NHL which were presented at the 2003 and 2004 American Society of Clinical Oncology (ASCO) meetings and the 2003 American Society of Hematology (ASH) meeting. Additionally, Millennium anticipates further data from two of these studies will be submitted for presentation at the December American Society of Hematology 46th annual meeting in San Diego, Calif.
Millennium and Johnson & Johnson Pharmaceutical Research & Development jointly continue to investigate VELCADE globally in both hematologic and solid tumors and currently have approximately 80 ongoing clinical trials.
VELCADE is currently approved in the United States, 27 European Union states, South Korea, Argentina and Israel. VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. will be responsible for Japan.
About Mantle Cell Lymphoma
Mantle cell lymphoma, an aggressive form of non-Hodgkin's lymphoma, accounts for approximately six percent of all lymphomas. This form of lymphoma is often widespread when diagnosed and typically involves the lymph nodes, bone marrow and spleen. Only one fifth of patients survive more than five years following diagnosis; median survival is three years.
About VELCADE® (bortezomib) for Injection
VELCADE is approved for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in survival. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, orthostatic hypotension, congestive heart failure, gastrointestinal adverse events, thrombocytopenia, and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.
In 228 patients who were treated with VELCADE 1.3 mg/m2/dose in phase II studies, the most commonly reported adverse events were asthenic conditions (65%), nausea (64%), diarrhea (51%), decreased appetite including anorexia (43%), constipation (43%), thrombocytopenia (43%), peripheral neuropathy (37%), pyrexia (36%), vomiting (36%), and anemia (32%). Fourteen percent of patients experienced at least one episode of Grade 4 toxicity, with the most common toxicities being thrombocytopenia (3%) and neutropenia (3%). A total of 113 (50%) of the 228 patients experienced Serious Adverse Events (SAEs) during studies. The most commonly reported SAEs included pyrexia (7%), pneumonia (7%), diarrhea (6%), vomiting (5%), dehydration (5%), and nausea (4%).
For more information about VELCADE® (bortezomib) for Injection clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE. |
