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%.