In this article Millennium Pharmaceuticals, Inc. discusses the results from its phase III confirmatory APEX trial which show a statistically significant improvement in survival in patients treated in the VELCADE alone arm compared to those treated with high-dose dexamethasone. These data include an approximate 30 percent reduction in the risk...
In this article Millennium Pharmaceuticals, Inc. discusses the initiation of a multicenter phase II clinical trial of VELCADE Bortezomib for injection in combination with rituximab in patients with relapsed or refractory indolent follicular and marginal zone non-Hodgkin's lymphoma. The randomized study will assess efficacy, overall safety and tolerability of the...
This article focuses and gives details on prescribing VELCADE which is 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. The effectiveness of VELCADE is based on response rates. The trials of VELCADE include...
In this article Millennium Pharmaceuticals, Inc. informs that the Center for Medicare and Medicaid Services CMS has qualified VELCADE for pass-through status and assigned it to a Healthcare Common Procedure Coding System HCPCS whereby hospitals may obtain reimbursement for VELCADE under the hospital outpatient prospective payment system OPPS effective October...
In this article Millennium Pharmaceuticals, Inc. discusses the results of several clinical trials with its novel oncology product VELCADE, in which early signs of anti-tumor activity were observed with VELCADE as both a single agent and in combination with other therapies. VELCADE Studied as a Single Agent in Non-Hodgkin's Lymphoma...
In this article Millennium Pharmaceuticals, Inc. informs about the approval from the U.S. Food and Drug Administration FDA to market VELCADE 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...
In this article Millennium Pharmaceuticals, Inc. reveals that the U.S. Food and Drug Administration FDA accepted for review and granted Priority Review designation of the Company's New Drug Application NDA for VELCADE for the treatment of relapsed and refractory multiple myeloma. Priority Review is granted by the FDA to an...
In this article Millennium Pharmaceuticals, Inc. informs that it has submitted a complete Marketing Authorization Application MAA to the European Agency for the Evaluation of Medicinal Products EMEA for the approval of bortezomib VELCADE as a treatment for relapsed and refractory multiple myeloma. This application was submitted approximately one week...
In this article Millennium Pharmaceuticals, Inc. informs that it has submitted a New Drug Application NDA with the U.S. Food and Drug Administration FDA for approval to market VELCADE as a treatment for relapsed and refractory multiple myeloma. In June 2002, VELCADE was granted fast-track status by the FDA as...
In this article Millennium Pharmaceuticals, Inc. elaborates and gives information about their final results of the phase II CREST study (previously known as 024) for its investigational cancer drug VELCADE in the treatment of patients with multiple myeloma whose cancer had relapsed following front-line treatment. The study also evaluated the...
In this article Millennium Pharmaceuticals, Inc. discusses their final results from the phase II SUMMIT trial (previously known as 025) for its investigational cancer drug VELCADE in patients with relapsed and refractory multiple myeloma that were progressing on their last prior therapy. The findings indicated that a majority of patients...
This article focuses on VELCADE which is a novel drug candidate that may have broad applications in cancer. In January 2003, Millennium submitted a New Drug Application NDA to the U.S. Food and Drug Administration FDA for approval to market VELCADE as a treatment for relapsed and refractory multiple myeloma....
In this article Millennium Pharmaceuticals, Inc. discusses the initiation of a pivotal phase III clinical trial of VELCADE (formerly known as MLN341, LDP-341 and PS-341) in patients with multiple myeloma, the second most common hematologic cancer. The company also announced they have filed the trade name VELCADE, for trademark registration,...
In this article Millennium Pharmaceuticals, Inc. discusses the recent initiation of a phase II clinical trial of VELCADE in patients with colorectal cancer. The randomized, open-label study assesses the response rates of patients with refractory metastatic colorectal cancer to treatment with VELCADE alone or VELCADE plus CamptosarR irinotecan hydrochloride injection....
In this article Millennium Pharmaceuticals, Inc. discusses the initiation of a phase II clinical trial of VELCADE in patients with stage IIIb locally advanced or stage IV metastatic non-small cell lung cancer NSCLC. The randomized, open-label study will assess response rates of patients with previously treated NSCLC to treatment with...
This article discusses the Millennium Pharmaceuticals, Inc. approval from the U.S. Food and Drug Administration FDA to market VELCADE 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...
In this article Millennium Pharmaceuticals, Inc. informs that the Company intends to file a New Drug Application NDA with the U.S. Food and Drug Administration FDA to market VELCADE as a treatment for relapsed and refractory multiple myeloma by early 2003. Earlier this year, VELCADE was granted fast-track status by...
In this article Millennium Pharmaceuticals, Inc. discusses the preliminary phase I study results, examining the use of its novel oncology product, VELCADE, in combination with DOXILR doxorubicin liposome injection for the treatment of patients with advanced stage multiple myeloma that have failed multiple prior treatments. Also presented was a combination...
In this article, Millennium Pharmaceuticals, Inc informs that the company, based on the recommendation of an independent data monitoring committee and the notification of regulatory authorities, is halting the control arm in the phase III APEX trial. This allows patients currently receiving dexamethasone the option to immediately crossover to VELCADE...
In this article Millennium Pharmaceuticals, Inc. informs that the U.S. Food and Drug Administration FDA accepted for review the Company's supplemental New Drug Application sNDA and granted Priority Review designation for VELCADE for the treatment of patients with multiple myeloma who have received at least one prior therapy. The submission...
