BEERSE, Belgium--(BUSINESS WIRE)--

Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has approved the use of VELCADE (bortezomib) as induction therapy (a first therapeutic option) in combination with dexamethasone (VD) or thalidomide and dexamethasone (VTD).1 This licence extension will apply to adult patients with previously-untreated multiple myeloma who are eligible for high-dose chemotherapy with haematological stem cell transplantation.

Until now, VELCADEs (bortezomib) indication has been limited to its use, in combination with melphalan and prednisone, in adult patients with multiple myeloma that are previously untreated and ineligible for stem cell transplant, and as a single agent in advanced multiple myeloma.2 Multiple myeloma, a type of blood cancer, currently affects around 60,000 people in Europe.3 This decision could mean significantly improved outcomes for many patients with this disease.

The approval by the EC was based on the analysis of data from two Phase III trials (IFM-2005-01, PETHEMA/GEM05) which demonstrated that treatment with VELCADE-based induction resulted in improvements in post-induction and post-transplant response rates and in progression-free survival (PFS); PFS and overall survival (OS) were secondary endpoints.

The trials studied the use of VELCADE-based regimens VD and VTD, compared to non-VELCADE-based regimens of vincristine plus doxorubicin and dexamethasone, or thalidomide and dexamethasone, respectively, as induction therapy prior to autologous stem cell transplant in adult patients with previously-untreated multiple myeloma.4,5

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Overview of the IFM-2005-01 and PETHEMA/GEM05 studies4,5

Study IFM-2005-01 evaluated VELCADE (bortezomib) in combination with dexamethasone (VD) compared to vincristine, plus doxorubicin and dexamethasone (VAD). The study included patients aged 65 or under with untreated symptomatic multiple myeloma, with measurable paraprotein in serum (over 10 g/L or urine over 0.2 g/24h).

Results demonstrated that complete response or near complete response rate was significantly improved in the VD group, with a 14.8 percent response rate compared to 6.4 percent [p = 0.004] in patients treated post induction therapy, and 35.0 percent compared to 18.4 percent [p

PFS was 36.0 months in the VD group compared to 29.7 months [p = 0.064] in the VAD group. The OS rate at the 3 year follow up was 81.4 percent in those receiving VD compared to 77.4 percent [p = 0.508] in those treated with VAD.

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European Commission Approves VELCADE® as a Frontline Induction Therapy before Stem Cell Transplantation