CHMP Gives a Positive Opinion for the Use of VELCADE® as Retreatment and for Frontline Induction Therapy before Stem …

BEERSE, Belgium--(BUSINESS WIRE)--

Janssen-Cilag International NV (Janssen) announced today that The Committee for Medical Products for Human Use (CHMP) of The European Medicines Agency (EMA) has granted a positive opinion on two variations relating to the use of VELCADE.1 VELCADE is indicated for the treatment of multiple myeloma, a type of blood cancer.

The first recommendation is for the use of VELCADE (bortezomib) as retreatment in adult patients who have previously responded to treatment with the same medicine.1 The positive opinion re-enforces the existing data supporting the use of VELCADE in this wider relapsedpatient population in the European Union. This is now included in the label and does not require an additional decision from the European Commission.

Concurrently, the CHMP also announced a positive opinion recommending the approval of VELCADE as induction therapy in combination with dexamethasone (VD) or dexamethasone and thalidomide (VDT). This is for adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematological stem cell transplantation.1 This will now bereferred for approval to the European Commission.

VELCADE was previously indicated for use in combination with melphalan and prednisone for the treatment of multiple myeloma in adult patients that are previously untreated but ineligible for high-dose chemotherapy with haematological stem cell transplant, and alone in advanced multiple myeloma. These label updates could mean significantly improved outcomes for many patients with this disease.

VELCADE(bortezomib) as retreatment therapy2

The submission for use of VELCADE in adult patients who have previously been treated with the medicine but have since relapsed is supported by data from the Phase II RETRIEVE (MMY2036) study. The primary objective of this study was best confirmed response at retreatment. This study included heavily pre-treated VELCADE patients, who had previously achieved a partial or greater response, and had at least six months since their previous VELCADE dose.

VELCADEas induction therapy prior to stem cell transplantation3,4

The submission for license extension was based on the analysis of data from two Phase III trials (IFM-2005-01, PETHEMA/GEM) which demonstrated that treatment with VELCADE-based induction resulted in improvements in progression-free survival (PFS), and post-induction and post-transplant response rates.

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

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CHMP Gives a Positive Opinion for the Use of VELCADE® as Retreatment and for Frontline Induction Therapy before Stem ...