Janssen has received a Final Appraisal Determination (FAD) from the National Institute of Health and Care Excellence (NICE) for the use of Velcade® (bortezomib) within its licensed indication for induction treatment in multiple myeloma.
In this indication bortezomib is licensed in combination with dexamethasone, or with dexamethasone and thalidomide, as induction treatment for adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.(1)
Bortezomib was the first of the class of anti-cancer drugs known as proteasome inhibitors (PI), and is an established therapy, as mono and combination treatment in relapsed myeloma, and in combination with melphalan and prednisolone in the front line treatment of myeloma.(1)
Myeloma is the second most common type of bone marrow cancer in the UK.(2) Around 4,700 people in the UK are diagnosed with myeloma each year.(2,3)
Induction treatment prior to high dose chemotherapy or haematopoietic stem cell transplantation in multiple myeloma is regarded as the standard of care for newly diagnosed patients who are under 65 years of age, and are able to tolerate treatment.(4) However, many of the traditional first-line treatment strategies have been characterised by lower response rates compared to regimens containing novel agents.(5) In studies, bortezomib-based induction regimens have demonstrated significantly higher overall response (OR) rates and higher post-induction and post-transplant complete response (CR) rates compared to the comparator regimens without it, regardless of disease stage or adverse cytogenic abnormalities.(6,7) Bortezomib-containing regimens have also demonstrated a favourable effect on progression free survival (PFS) in the induction setting versus the comparator regimens.(6,7)
Peter Barnes, Medical Director at Janssen, commented: “Janssen is pleased with the FAD for bortezomib in the induction setting. This builds on the well-recognised utility of bortezomib in other stages of multiple myeloma. Haematology is an area where there continues to be unmet medical need, and remains an important focus in our research efforts to bring new treatment options to patients.”
References:
- Velcade Summary of Product Characteristics available at: http://www.medicines.org.uk/emc/medicine/17109/SPC/ (Accessed 18 March 14)
- Myeloma UK – Facts and figures Available at: http://www.myeloma.org.uk/information/facts-and-figures/ (Accessed 18 March 14)
- Cancer Research UK – Key facts. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/keyfacts/myeloma/(Accessed 18 March 14)
- Ludwig, H et al. Multiple Myeloma Treatment Strategies with Novel Agents in 2011: A European Perspective. The Oncologist 2011;16:388-403
- Jagganath, S. Current Standards for First-Line Therapy of multiple Myeloma. Clin Lymphoma & Myeloma. 2007 7(5):S207-S214
- Harousseau, J-L et al. Bortezomib Plus Dexamethasone Is Superior to Vincristine Plus Doxorubicin Plus Dexamethasone As Induction Treatment Prior to Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: Results of the IFM 2005-01 Phase III Trial. J Clin Oncol 2010;28:4621-4629
- Rosiñol, L et al. Superiority of bortezomib, thalidomide, and dexamethasone (VTD) as induction pretransplantation therapy in multiple myeloma: a randomized phase 3 PETHEMA/GEM study. Blood 2012;120:1589-1596
- Myeloma UK – Velcade and Myeloma. Infoguide Series. Available at: http://www.myeloma.org.uk/information/myeloma-uk-publications-list/myeloma-treatment/velcade-infoguide/ (Accessed 18 March 14)
- Myeloma UK – What is the life expectancy for myeloma patients? Available at: http://www.myeloma.org.uk/information/frequently-asked-questions/faq-myeloma-the-basics/ (Accessed 18 March 14)
