Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its re­quest for an accelerated assess­ment of the dara­tu­mu­mab Marketing Authorisation Application (MAA). This acceptance follows the earlier regu­la­tory sub­mission of a MAA which seeks authori­sa­tion of dara­tu­mu­mab as a single agent for the treat­ment of patients with re­lapsed and refractory multiple myeloma and is cur­rently pend­ing val­i­da­tion by the EMA.

The CHMP grants accelerated assess­ment when a medicinal prod­uct is ex­pec­ted to be of major public health interest particularly from the point of view of thera­peutic inno­va­t.

Daratumumab is an inves­ti­ga­tional, human anti-CD38 mono­clonal anti­body that works by binding to CD38, a signalling molecule found on the surface of multiple myeloma cells.^1,2,3,4 In doing so, dara­tu­mu­mab triggers the patient’s own immune sys­tem to attack the cancer cells, resulting in rapid tumour cell death through mul­tiple immune-mediated and other mech­a­nisms of action.⁵

The MAA in­cludes data from the Phase 2 MMY2002 (SIRIUS) mono­therapy study, presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO),⁶ and data from the Phase 1/2 GEN501 mono­therapy study, recently published in The New England Journal of Medicine,⁷ and data from three addi­tional sup­port­ive studies.

“Janssen is pleased with the CHMP’s acceptance of an accelerated regu­la­tory review timeline for dara­tu­mu­mab, which reflects the high unmet need for new treat­ment options for patients with multiple myeloma, cur­rently an incurable disease,” said Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East and Africa. “We con­tinue to work closely with European health author­i­ties to make dara­tu­mu­mab avail­able to these patients as soon as possible.”

In July 2013 dara­tu­mu­mab was granted Orphan Drug Status by the EMA for the treat­ment of plasma cell myeloma.⁸ Further­more, this step for­ward in Europe also follows the acceptance for Priority Review of the Biologics License Application for dara­tu­mu­mab with the U.S. FDA on September 4, 2015.

In August 2012, Janssen Biotech, Inc. and Genmab entered an agree­ment which granted Janssen an exclusive world­wide license to develop, manu­fac­ture, and commercialise dara­tu­mu­mab.

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is char­ac­ter­ised by an excessive proliferation of plasma cells.⁹ MM is the second most common form of blood cancer, with around 39,000 new cases in Europe in 2012.¹⁰ MM most commonly affects people over the age of 65 and is more common in men than in women.¹¹ Across Europe, five-year survival rates are 23 per­cent to 47 per­cent of people diag­nosed.¹² Almost 29 per­cent of patients with MM will die within one year of diag­nosis.¹³ Al­though treat­ment may result in remission, unfortunately patients will most likely relapse as there is cur­rent­ly no cure. While some patients with MM have no symp­toms at all, most patients are diag­nosed due to symp­toms which can in­clude bone problems, low blood counts, cal­cium elevation, kidney problems or in­fec­tions.¹¹ Patients who relapse after treat­ment with standard ther­a­pies, in­­clud­ing pro­te­a­some inhibitors (PIs) and immuno­modu­la­tory agents (IMiDs), have poor prognoses and few treat­ment options avail­able.¹⁴

About Dara­tu­mu­mab

Daratumumab is an inves­ti­ga­tional human mono­clonal anti­body that binds with high affinity to the CD38 molecule, which is found on the surface of multiple myeloma cells. It is believed to induce rapid tumour cell death through multiple immune-mediated mech­a­nisms, in­­clud­ing complement-dependent cyto­tox­icity, anti­body-dependent cellular phagocytosic and anti­body-dependent cellular cyto­tox­icity, as well as via induction of apop­tosis.⁵ Five Phase 3 clin­i­cal studies with dara­tu­mu­mab in re­lapsed and frontline settings are cur­rent­ly ongoing. Additional studies are ongoing or planned to assess its poten­tial in other malignant and pre-malignant diseases in which CD38 is ex­pressed, such as smoul­der­ing myeloma and non-Hodgkin lym­phoma.

About Janssen

The 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 www.janssen-emea.com. Follow us on www.twitter.com/janssenEMEA for our latest news.

Janssen Pharma­ceu­tical NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., and Janssen-Cilag Inter­na­tional NV are part of the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson.

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 a focus on haematologic malig­nan­cies, prostate cancer and lung 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; as well as safe and effective identi­fi­ca­tion and treat­ment of early changes in the tumour micro­environment.

Cautions Concerning Forward-Looking Statements

This press release con­tains "forward-looking state­ments" as defined in the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 re­gard­ing the approval of a new indi­ca­tion. 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 known or unknown risks or un­cer­tain­ties ma­teri­alize, actual results could vary ma­teri­ally from the ex­pec­ta­tions and projections of any of the Janssen Pharma­ceu­tical Com­panies and/or Johnson & Johnson. Risks and un­cer­tain­ties in­clude, but are not limited to: chal­lenges and un­cer­tain­ties in­her­ent in new prod­uct devel­op­ment, in­­clud­ing uncertainty of clin­i­cal success and obtaining regu­la­tory approvals; uncertainty of commercial success; com­pe­ti­tion, in­­clud­ing technological ad­vances, new prod­ucts and patents attained by com­pet­i­tors; chal­lenges to patents; prod­uct efficacy or safety con­cerns resulting in prod­uct recalls or regu­la­tory action; changes in behaviour and spending patterns or financial distress of purchasers of health care prod­ucts and services; changes to appli­­cable laws and reg­u­la­tions, in­­clud­ing global health care reforms; manu­fac­tur­ing dif­fi­culties and delays; and trends to­ward health care cost con­tainment. 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 28, 2014, in­­clud­ing in Exhibit 99 thereto, and the com­pany’s sub­se­quent filings with the Se­cu­ri­ties and Exchange Com­mis­sion. Copies of these filings are avail­able online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharma­ceu­tical Com­panies or Johnson & Johnson under­takes to update any for­ward-looking state­ment as a result of new in­­for­ma­tion or future events or devel­op­ments.

References

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Source: Janssen.