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Velcade News Archive

01.07.10   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.

09.29.08   THE INTERNATIONAL MYELOMA FOUNDATION APPLAUDS EXPANSION OF VELCADE® FOR PREVIOUSLY UNTREATED PATIENTS IN EUROPE AND CANADA
With these new approvals, patients with multiple myeloma may now receive VELCADE earlier following an initial disease diagnosis.

08.28.08   AN EDITORIAL BY DR. BRIAN DURIE FEATURED IN THE NEW ENGLAND JOURNAL OF MEDICINE
Dr. Durie says that the statistics from the VISTA trial leave no doubt that combination therapy with bortezomib is superior to MP alone. However, he raises the issue, "how does this clear-cut evidence inform treatment decisions?"

06.26.08   PREVIOUSLY UNTREATED PATIENTS COULD BENEFIT FROM FDA APROVAL OF VELCADE® FOR 'FRONT-LINE' USE
New Indication Provides Treatment-Free Interval As an Option

10.15.07   FDA EXPANDS VELCADE® LABEL FOR MYELOMA
The FDA granted approval for VELCADE use, without dose adjustments, in patients with impaired kidney function, including those requiring dialysis. Impaired kidney function is a common complication related to myeloma, affecting approximately 30% of patients at diagnosis and a much larger percentage throughout the course of the disease.

09.20.07   INTERIM FINDINGS FROM GLOBAL TRIAL EXTEND POSITIVE BENEFITS OF VELCADE TO NEWLY DIAGNOSED PATIENTS
The combination therapy of VELCADE, melphalan and prednisone (VMP) demonstrates a significant advantage for patients newly diagnosed with myeloma. The therapy is already approved for use in patients who have received a previous treatment.

09.19.07   VISTA Trial Halted because of Better than Expected Interim Results
Interim analysis results of the large, international Phase III VISTA(1) trial in patients with newly diagnosed multiple myeloma showed that the therapy of VELCADE, melphalan and prednisone (VMP) demonstrated a highly statistically significant improvement in all efficacy measures.

06.04.07   STUDY SHOWS VELCADE® PLUS DOXIL® IMPROVES SURVIVAL IN PREVIOUSLY TREATED PATIENTS WITH MYELOMA
Data Presented at the ASCO Cancer Conference

05.21.07   THE INTERNATIONAL MYELOMA FOUNDATION REPORTS NEW DRUG COMBINATION - VELCADE® PLUS DOXIL® - APPROVED FOR MYELOMA
Combination Provides 43% Improvement in Time to Disease Progression

05.21.05   VELCADE® Overcomes Poor Prognosis of del(13) In Multiple Myeloma
According to results recently presented at the 2005 ASCO meeting, treatment with Velcade (bortezomib) may overcome the poor prognosis associated with del(13), considered a poor prognostic indicator for survival in multiple myeloma.

04.29.05   VELCADE® for injection receives EU authorisation for second-line use in multiple myeloma
The European Commission has approved the use of VELCADE® (bortezomib) for Injection as a second-line treatment in patients with multiple myeloma.

03.25.05   FDA Approves VELCADE® for Use in Second-Line Multiple Myeloma
This approval expands the label to include the treatment of multiple myeloma patients who have received at least one prior therapy. The approval was based on data from the randomized Phase III APEX study that compared single-agent VELCADE to high-dose dexamethasone. The study demonstrated a statistically significant survival advantage in the VELCADE arm of the study.

05.11.04   FDA Approves VELCADE® for Multiple Myeloma Treatment

06.11.04   New results for VELCADE® in previously untreated myeloma

06.11.04   New results for VELCADE® in relapsed myeloma