Janssen-Cilag, a research-based pharmaceutical company, has received the European Commission approval for 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.
Velcade (bortezomib) is a medicine used to treat the blood based cancer known as multiple myeloma. It contains an active substance called Bortezomib and is the first in a new class of medicines known as proteasome inhibitors.
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).
Janssen-Cilag said that 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 improved overall survival of 68.5% for patients treated with Bortezomib plus melphalan and prednisone (Vc+M+P), compared to 54% for patients on melphalan and prednisone (M+P) alone after three years of treatment.
The study also showed a higher complete response rate of 30% for Vc+M+P versus four% 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.
The data presented shows 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.
Reportedly, 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%.