BEERSE, Belgium, December 19, 2014 /PRNewswire/ --
Janssen-Cilag International NV (Janssen) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of VELCADE® (bortezomib) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for haematopoietic stem cell transplantation.[1]
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MCL is a rare and aggressive type of blood cancer that can be challenging to treat and is associated with a poor prognosis.[2],[3] The positive opinion of the CHMP was based on data from the Phase 3 study, LYM-3002. In the European Union (EU), VELCADE is currently indicated for the treatment of multiple myeloma (MM), another rare blood cancer, either as monotherapy or in combination with of other treatment regimens.[4]
"At Janssen, we are committed to continuously developing therapeutic solutions to treat relevant, haematologic diseases like MCL," said Thomas Stark, Vice President, Medical Affairs, Janssen Europe, Middle East and Africa (EMEA). "This positive opinion brings us one step closer to offering additional treatment options with VELCADE for patients and physicians, and we are delighted with this recommendation."
Study Efficacy Results[ 5]
LYM-3002 was a randomised, open-label, active-controlled, multicentre, international, prospective Phase 3 study including 487 patients with newly diagnosed MCL who were ineligible, or not considered, for bone marrow transplantation.
The results showed significant benefits when treating newly diagnosed patients with MCL using a VELCADE-based combination (VR-CAP[*]), compared to a widely used standard of care combination not including VELCADE (R-CHOP[**]). The VR-CAP regimen significantly improved progression-free survival (PFS), the primary endpoint, and showed improvements across a range of secondary endpoints.[5] An independent review committee reported the increase in PFS to be 59 percent (median 24.7 vs. 14.4 months; HR 0.63; p<0.001), whereas the study investigators reported the increase in PFS to be 96 percent (median 30.7 vs. 16.1 months; HR 0.51; p<0.001).[5]
Safety Results
VR-CAP was associated with additional, but manageable, toxicity when compared to VR-CHOP.[5] Overall, among patients receiving VR-CAP compared to R-CHOP, serious adverse events (AE) were reported in 38 percent vs. 30 percent of patients and grade ≥3 AEs were reported in 93 percent vs. 85 percent. Discontinuations of treatment due to AEs were nine percent (VR-CAP) vs. seven percent (R-CHOP) and on-treatment drug-related deaths were two percent vs. three percent.[5]
The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to grant a label extension for medicines in the European Economic Area. A final decision on VELCADE's use in MCL by the European Commission is anticipated early next year.
About the CHMP
The CHMP is the committee responsible for the scientific assessment of products seeking centralised marketing authorisation throughout the European Union. The positive opinion for VELCADE is now referred for approval to the European Commission (EC) who will decide on whether to follow its guidance and grant authorisation for commercialisation of VELCADE as a treatment option for MCL.
About VELCADE (bortezomib)
VELCADE is a medicine currently licensed in the EU for the treatment of multiple myeloma (MM), a blood-based cancer, and is currently indicated for:[4]
VELCADE contains an active substance called bortezomib and is the first in a specific class of medicines known as proteasome inhibitors. Proteasomes are present in all cells and play an important role in controlling cell function, growth and also how cells interact with other cells around them. Bortezomib reversibly interrupts the normal working of cell proteasomes, inducing the cancerous cells, to stop growing and die.[6]
VELCADE has a predictable safety profile and a favourable benefit-risk ratio. The most common side effects reported with VELCADE (bortezomib) include fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy.[4]
VELCADE is commonly used in the treatment of various stages of MM. The product is co-developed by Millennium, the Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, and Janssen Pharmaceutical Companies. Millennium is responsible for commercialisation of VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for commercialisation in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 550,000 patients worldwide.
VELCADE in MCL
In Europe, VELCADE is not currently licensed to treat MCL. In 2006, the U.S. Food and Drug Administration (FDA) approved VELCADE for the treatment of patients with MCL who have received at least one prior therapy, with a subsequent frontline treatment approval in October 2014 for VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP). VELCADE has also been approved for the treatment of relapsed MCL in 53 additional countries, including Canada and Switzerland. If endorsed by the European Commission, the positive opinion from the CHMP recommending the approval of VELCADE for the treatment of MCL would provide an additional treatment option for MCL patients in the European Union.
About MCL
MCL is considered a rare disease, characterised by high unmet need and small patient populations impacting fewer than 0.45 in 100,000 people in Europe and with a median age at diagnosis of 65.[7],[8] MCL is much more predominant in men than women and accounts for six percent of all non-Hodgkin's lymphomas.[9],[10] Median overall survival is typically four to five years, and only one to two years in patients following the first relapse.[11],[12] MCL typically involves the lymph nodes, but can spread to other tissues, such as the bone marrow, liver, spleen and gastrointestinal tract.[8] This challenging disease is associated with poor prognoses.
Janssen in Oncology
In oncology, our goal is to fundamentally alter the way cancer is understood, diagnosed, and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include disease area strongholds that focus on haematologic malignancies and prostate cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualised use of our therapies; and safe and effective identification and treatment of early changes in the tumour microenvironment.
About Janssen
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found on http://www.janssen-emea.com. Follow us on http://www.twitter.com/janssenEMEA for our latest news.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; general industry conditions including trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov,http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.)
[*]VELCADE, rituximab, cyclophosphamide, doxorubicin and prednisone (VR-CAP)
[**]Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP)
REFERENCES
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PHEM/VEL/1114/0001 December 2014
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