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Published on 17 June 2010

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EMEA approves update to Velcade (bortezomib)

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Janssen-Cilag has welcomed the approval by the European Commission of the update to the Summary of Product Characteristics (SmPC) for Velcade (bortezomib) for the treatment of patients with multiple myeloma.

The update includes data on overall survival rates. The decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA).

The CHMP reviewed clinical evidence from a prospectively defined survival update of the phase III international VISTA (Velcade as Initial Standard Therapy in Multiple Myeloma) study, which shows a significantly improved overall survival of 68.5% for patients treated with bortezomib plus melphalan and prednisone (Vc+M+P), compared to 54% (p=0.0008) for patients on melphalan and prednisone (M+P) alone after three years of treatment. The study also showed a significantly higher complete response rate of 30% for Vc+M+P versus 4% for M+P alone.

The Pharmacological Properties section of the SmPC for bortezomib now includes these updated efficacy results, following the pre-planned survival follow-up analysis in the VISTA study.

In addition, data from more than ten studies of bortezomib in a number of different treatment settings were presented this weekend at the 15th Congress of the European Hematology Association in Barcelona.

The data presented highlights the evidence supporting the use of bortezomib as first line (in non-transplant eligible patients) and second line therapy and includes; data from RETRIEVE (Petrucci et al.), a large international phase II study on retreatment with bortezomib in patients who had previously responded, demonstrating the efficacy of bortezomib as a retreatment option; and a phase II trial (Dimopoulos et al.) of bortezomib as a second line treatment in patients with relapsed or refractory multiple myeloma – which showed an overall response rate of 83.7%.

Multiple myeloma, a cancer of the blood, is the second most common haematologic malignancy. Traditionally, multiple myeloma is associated with a poor prognosis, with a median survival of 3–5 years from diagnosis.

Although the disease remains incurable with conventional therapy, the outlook for many  patients has improved in the last few years due to advances in novel therapies, such as bortezomib, which are increasingly being incorporated into present-day treatment practices.

Janssen-Cilag



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