VELCADE® (bortezomib) has been approved today in the UK for the first-line treatment of Mantle Cell Lymphoma (MCL), an aggressive subtype of blood cancers, collectively known as Non-Hodgkin Lymphoma (NHL). Recent clinical trial results have shown that patients with previously untreated MCL, who were unsuitable for blood stem-cell transplantation, had an improvement in progression free survival (PFS) compared to the control arm when treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (VR-CAP).

In the UK, approximately one in every twenty-five people will be diagnosed with a blood- based cancer during their lifetime.1 NHL is the sixth most common cancer in the UK, with latest data showing that more than 45,000 people are currently living with the disease.2 Of these, 1 in 20 people are affected by MCL (5%),2 which has a poor prognosis with fewer than three in ten patients surviving the disease for five years or more.3

Professor Simon Rule, Consultant Haematologist at Derriford Hospital, Plymouth, said: "The launch of bortezomib is a step forward in the treatment of MCL and represents a significant advance in this disease setting."

"Bortezomib is already a well-known and widely used drug for the treatment of multiple myeloma. This launch in MCL is exciting as it represents a real change in the blood- based cancer treatment landscape and means that patients with the disease can experience a sustained disease-free period." The approval of bortezomib for the treatment of MCL was based on data from the Phase 3 study, LYM-3002.4 The trial demonstrated that treatment with VR-CAP significantly improved PFS in MCL patients, with an increase in median PFS shown to be 59 percent higher compared to treatment with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (24.7 vs. 14.4 months; HR 0.63; p<0.001).

Monica Izmajlowicz, CEO of Leukaemia CARE, said: "Receiving a diagnosis of MCL is devastating for both the patients themselves and their friends and family. MCL has a very poor prognosis and is an aggressive disease, particularly when compared with other blood-based cancers. Treatment options have also been very limited until recently."

"The launch of bortezomib in MCL, therefore, represents a welcome addition in the treatment of this disease, which will hopefully show significant benefits for patients in the UK diagnosed with MCL in the future."

Mark Hicken, Managing Director of Janssen, stated: "At Janssen we are proud of our haematology portfolio and are committed to extending and improving the lives of people living in the UK and around the world with blood-based cancers such as MCL. We want to ensure that as many eligible patients as possible have access to our treatments. Therefore, we have submitted an application to the National Cancer Drugs Fund (nCDF) and will submit an application to the National Institute for Health and Care Excellence (NICE) for bortezomib for the treatment of MCL. We expect the outcomes from these reimbursement decisions to come in 2015 and 2016 respectively."

About bortezomib

Bortezomib, a proteasome inhibitor, works by interrupting the normal function of cell proteasomes, causing susceptible cancer cells to stop growing and die.5, 6 Bortezomib has been licensed for the treatment of multiple myeloma, a blood-based cancer, since 2004.

Bortezomib has a predictable safety profile.7 The most common side effects reported with bortezomib include fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy.5

About bortezomib in MCL

The approval of bortezomib for the first-line treatment of MCL has been granted by the European Commission (EC), which is the authority for providing marketing authorisation for medicines within countries that are members of the European Union, including the UK.

The US Food and Drug Administration (FDA) has approved bortezomib for the treatment of patients with MCL who have received at least one prior therapy, and bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) for first-line treatment of MCL. Bortezomib has also been approved for the treatment of relapsed MCL in 53 additional countries, including Canada and Switzerland.

About MCL

MCL is a rare and aggressive B-cell lymphoma. Around 500 people a year in the UK are diagnosed with MCL.2 MCL patients generally have a poor prognosis. Fewer than three in 10 MCL patients will survive their disease for five years or more.3

About the LYM-3002 study

The approval of bortezomib for the treatment of MCL was based on data from the LYM- 3002 trial, which was a randomised, open-label, multicentre, international Phase 3 study.4 The study was one of the largest ever conducted in MCL and included 487 patients with newly diagnosed MCL who were ineligible, or not considered, for bone marrow transplantation.4

The results showed that treatment with the VR-CAP regimen significantly improved progression-free survival (PFS) compared to R-CHOP, with a reported increase in median PFS of 59 percent (24.7 vs. 14.4 months). The four year survival rate also showed a trend towards prolonged survival with VR-CAP (64.4% vs. 53.9%).4