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- Millennium Announces VELCADE (Bortezomib) for Injection has Significantly Extended Survival in Phase III (APEX) Trial of Patients With Relapsed Multiple Myeloma
- In this article Millennium Pharmaceuticals, Inc. discuses their final survival endpoint analysis in the phase III confirmatory APEX study comparing patients receiving VELCADE to those receiving high-dose dexamethasone, VELCADE produced a statistically significant survival benefit. The study was designed to include survival as a secondary endpoint and allowed crossover for...
- White papers
- Preliminary Study Results of VELCADE (Bortezomib) for Injection Combined With Thalidomide Demonstrated Anti-Tumor Activity in Patients With Advanced Multiple Myeloma
- In this article, Millennium Pharmaceuticals, Inc. gives promising preliminary phase I/II study results from an investigator initiated study IIS examining the use of VELCADE in combination with thalidomide for the treatment of patients with advanced stage multiple myeloma that have failed several prior treatments. A formal phase I study assessing...
- White papers
- VELCADE (Bortezomib) for Injection Shows Promising Activity in Two Phase II Studies of Patients With Previously Untreated Multiple Myeloma
- In this article Millennium Pharmaceuticals, Inc. displays the encouraging data from two ongoing phases II investigator-sponsored clinical trials examining the potential role of VELCADE in patients with previously untreated multiple myeloma. The trials are examining VELCADE alone and in combination with standard treatments, including dexamethasone and doxorubicin.
- White papers
- Millennium Files Supplemental New Drug Application for VELCADE (bortezomib) for Injection for the Treatment of Patients With Second-Line Multiple Myeloma
- In this article Millennium Pharmaceuticals, Inc. discusses the submission of the Company's supplemental New Drug Application sNDA to the U.S. Food and Drug Administration FDA for VELCADE for the treatment of patients with multiple myeloma who have received at least one prior therapy, a patient population of approximately 22,000 in...
- White papers
- FDA Grants VELCADE (Bortezomib) for Injection Fast Track Status for Relapsed and Refractory Mantle Cell Lymphoma
- In this article Millennium Pharmaceuticals, Inc. informs 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...
- White papers
- FDA Accepts sNDA Filing With Priority Review for VELCADE (Bbortezomib) for Injection to Treat Second-Line Multiple Myeloma
- 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...
- White papers
- New Phase II Findings Support Potential Role of VELCADE (Bortezomib) for Injection in Patients With Non-Hodgkin's Lymphoma
- In this article Millennium Pharmaceuticals, Inc gives the results of two clinical trials with VELCADE in patients with non-Hodgkin's lymphoma NHL, in which early signs of anti-tumor activity were observed. VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and, if necessary, dose modification). VELCADE is contraindicated in...
- White papers
- Preliminary Phase II Results With VELCADE (Bortezomib) for Injection Demonstrated Activity in Patients With Previously Untreated Multiple Myeloma
- In this article Millennium Pharmaceuticals, Inc. discusses the encouraging preliminary phase II study results from an investigator-initiated study IIS examining the use of VELCADE for the treatment of patients with previously untreated multiple myeloma. The ongoing study being conducted by Dr. Jagannath, M.D., Brian Durie, M.D., of Salick Health Care,...
- White papers
- Millennium Initiates Phase II Clinical Trial With VELCADE (Bortezomib) for Injection in Patients With Relapsed or Refractory Mantle Cell Lymphoma
- In this article Millennium Pharmaceuticals, Inc. discusses the initiation of a multicenter phase II clinical trial of VELCADE in patients with relapsed or refractory mantle cell lymphoma. The single-arm, open-label, three-stage study will assess time to progression, response rate, duration of response and overall survival in patients with relapsed or...
- White papers
- Millennium Announces Promising Early Study Results With VELCADE (Bortezomib) for Injection Combined With Doxil in Patients With Advanced Multiple Myeloma
- 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...
- White papers
- FDA Approves VELCADE (Bortezomib) for Injection for the Treatment of Relapsed and Refractory Multiple Myeloma
- 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...
- White papers
- Millennium Initiates Phase II Clinical Trial With Velcade (Bortezomib) for Injection fn Patients With Advanced Non-Small Cell Lung Cancer
- 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...
- White papers
- Millennium Initiates Phase II Clinical Trial With VELCADE (Bortezomib) for Injection in Patients With Colorectal Cancer
- 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....
- White papers
- Millennium Plans to Submit a New Drug Application for Velcade (Bortezomib) for Injection
- 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...
- White papers
- Independent Committee Recommends Early End to Confirmatory Phase III VELCADE Trial Based on Achieving Statistically Significant Improvement in Primary Endpoint
- 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...
- White papers
- Takeda's Spree Peaks With Millennium Buy
- The Japanese are coming! Well, to be exact, one Japanese drugmaker, Takeda Pharmaceutical, is coming. And the big question is whether its recent buying spree -- capped by its $8.8 billion acquisition of the biotech Millennium Pharmaceuticals announced today -- will leave it looking more like...
- Blog posts 2008-04-11
- VELCADE (Bortezomib) for Injection Data Show a Significant Improvement in Survival in Patients With Relapsed Multiple Myeloma
- 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...
- White papers 2004-06-05
- Millennium Initiates Phase II Clinical Trial With VELCADE and Rituximab in Patients With Indolent Non-Hodgkin's Lymphoma
- 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...
- White papers 2004-05-13
- VELCADE (Bortezomib) for Injection: Prescribing Information
- 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...
- White papers 2004-04-14
- Millennium Announces Assignment of Medicare Code for Velcade (Bortezomib) for Injection
- 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...
- White papers 2003-09-26
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