VELCADE® Adds Long-Term Overall Survival Benefit to Label
With suvivival data from VISTA trial, FDA makes VELCADE first front-line multiple myeloma therapy to include overall survival benefit after three-year follow-up in label.
|
|
|
01.07.10 |
|
The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM). The updated survival data, presented at the 51st Annual Meeting of the American Society of Hematology (ASH), confirmed the OS benefit observed at the original interim analysis that led to the front-line approval of VELCADE in MM in June 2008.
For more information, click here to view the press release.
|
 related videos  related articles |
Developing a SNP Classifier for Predicting Peripheral Neuropathy by Bortezomib in Multiple Myeloma Patients
Genetic Associations with Therapy Response in the HOVON-65/GMMG-HD4 Trial in Patients with Multiple Myeloma
ASH 2009: Antonio Palumbo
Bortezomib, Melphalan, Prednisone and Thalidomide (VMPT) Followed by Maintenance with Bortezomib and Thalidomide for Initial Treatment of Elderly Multiple Myeloma Patients
ASH 2009: Choon Kee Lee
An Outcome Study On Survival and Disease Control in Patients with High-Risk Multiple Myeloma (MM) for Relapse, Treated with High-Dose Melphalan Combined with Bortezomib for Autotransplant Followed by Post-Transplant Maintenance with Bortezomib and Lenalidomide
ASH 2009: David Siegel
Update On the Phase IIb, Open-Label Study of Vorinostat in Combination with Bortezomib in Patients with Relapsed and Refractory Multiple Myeloma
ASH 2009: Heinz Ludwig
Bortezomib, Thalidomide, and Dexamethasone (VTD) Versus VTD Plus Cyclophosphamide as Induction Therapy in Previously Untreated Multiple Myeloma Patients Eligible for HDT-ASCT: A Randomized Phase 2 Trial
ASH 2009: Hervé Avet Loiseau
Induction with Velcade®/Dexamethasone Partially Overcomes the Poor Prognosis of t(4;14), but Not That of Del(17p), in Young Patients with Multiple Myeloma
ASH 2009: Jean-Luc Harousseau
Bortezomib Plus Dexamethasone (VD)Versus Reduced-dose bortezomib Plus Thalidomide Plus Dexametasone (vTD) as Induction Treatment Prior to Autologous Stem-Cell Transplantation (ASCT) in Newly Diagnosed Multiple Myeloma (MM)
ASH 2009: Jean-Luc Harousseau
High Complete and Very Good Partial Response Rates with Bortezomib–Dexamethasone as Induction Prior to ASCT in Newly Diagnosed Patients with High-Risk Myeloma: Results of the IFM2005-01 Phase 3 Trial
ASH 2009: Maria-Victoria Mateos
Bortezomib Plus Melphalan–Prednisone Continues to Demonstrate a Survival Benefit Vs Melphalan–Prednisone in the Phase III VISTA Trial in Previously Untreated Multiple Myeloma After 3 Years’ Follow-up and Extensive Subsequent Therapy Use
ASH 2009: Nilanjan Ghosh
Bortezomib and Thalidomide, a Steroid Free Regimen in Newly Diagnosed Patients with Multiple Myeloma
ASH 2009: Paul Richardson
High Response Rates and Encouraging Time-to-Event Data with Lenalidomide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma: Final Results of a Phase I/II Study
ASH 2009: Paul Richardson
Perifosine in Combination with Bortezomib and Dexamethasone Extends Progression-Free Survival and Overall Survival in Relapsed/Refractory Multiple Myeloma Patients Previously Treated with Bortezombib: Updated Phase I/II Trial Results
ASH 2009: Paul Richardson
Tanespimycin + Bortezomib Demonstrates Safety, Activity, and Effective Target Inhibition in Relapsed/Refractory Myeloma Patients: Updated Results of a Phase 1/2 Study
ASH 2009: Pieter Sonneveld
Developing a SNP Classifier for Predicting Peripheral Neuropathy by Bortezomib in Multiple Myeloma Patients
ASH 2009: Ruben Niesvizky
Phase 3b UPFRONT Study: Interim Results From a Community Practice-Based Prospective Randomized Trial Evaluating Three Bortezomib-Based Regimens in Elderly, Newly Diagnosed Multiple Myeloma Patients
ASH 2009: Sagar Lonial
A Phase I Clinical Trial Testing the Combination of Bortezomib and Tipifarnib in Relapsed/Refractory Multiple Myeloma
ASH 2009: Shaji Kumar
Natural History of Multiple Myeloma Relapsing After Therapy with IMiDs and Bortezomib: A Multicenter International Myeloma Working Group Study
ASH 2009: Shaji Kumar
Novel Three– and Four–Drug Combinations of Bortezomib, Dexamethasone, Cyclophosphamide, and Lenalidomide, for Newly Diagnosed Multiple Myeloma: Encouraging Results From the Multi-Center, Randomized, Phase 2 EVOLUTION Study
ASH 2009: Sophie L. Corthals
Genetic Associations with Therapy Response in the HOVON-65/GMMG-HD4 Trial in Patients with Multiple Myeloma
ASH 2009: Sundar Jagannath
The Combination of Vorinostat and Bortezomib Provides Long-Term Responses in Patients with Relapsed or Refractory Multiple Myeloma
back
print