Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced that the European Com­mis­sion has granted mar­ket­ing authori­sa­tion to provide health­care professionals with the option to split the first in­fusion of Darzalex® (dara­tu­mu­mab) over two consecutive days.

“We are committed to the devel­op­ment of new treat­ments, com­bi­na­tions, and for­mu­la­tions that will sup­port people living with multiple myeloma across the full disease spectrum,” said Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen. “This is an im­por­tant de­ci­sion for health­care professionals and patients, as it provides flexibility in admin­istra­tion that may help address individual patient needs.”

The de­ci­sion was based on data from the Phase 1b EQUULEUS (MMY1001) clin­i­cal trial, which dem­onstrated dara­tu­mu­mab phar­ma­co­ki­netics con­cen­tra­tions were com­parable re­gard­less of whether the first dose was admin­istered as a split in­fusion or single first in­fusion in patients with multiple mye­lo­ma.¹ The safety profile of dara­tu­mu­mab was com­parable when admin­istered initially as a split or single dose.¹

The approval follows the Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 19 November 2018.²

About dara­tu­mu­mab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly ex­pressed across multiple myeloma cells, re­gard­less of disease stage.³ Dara­tu­mu­mab is believed to induce tumour cell death through multiple immune-mediated mech­a­nisms of action, in­­clud­ing complement-dependent cyto­tox­icity (CDC), anti­body-dependent cell-mediated cyto­tox­icity (ADCC) and anti­body-dependent cellular phago­cytosis (ADCP), as well as through apop­tosis, in which a series of molecular steps in a cell lead to its death.4 A subset of myeloid derived sup­pressor cells (CD38+ MDSCs), CD38+ regu­la­tory T cells (Tregs) and CD38+ B cells (Bregs) were de­creased by dara­tu­mu­mab.⁴ Dara­tu­mu­mab is being eval­u­ated in a com­pre­hen­sive clin­i­cal devel­op­ment pro­gramme across a range of treat­ment settings in multiple myeloma, such as in frontline and re­lapsed settings.^{5,6,7,8,9,10,11,12} Additional studies are ongoing or planned to assess its poten­tial in other malignant and pre-malignant haematologic diseases in which CD38 is ex­pressed, such as smoul­der­ing myeloma.^13,14 For more in­for­ma­tion, please see www.clinicaltrials.gov.

In Europe, dara­tu­mu­mab is indicated for use in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant, as mono­therapy for the treat­ment of adult patients with re­lapsed and refractory multiple myeloma, whose prior ther­apy in­cluded a pro­te­a­some inhibitor and an immuno­modu­la­tory agent and who have dem­onstrated disease pro­gres­sion on the last ther­apy, and in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy.⁴ For further in­for­ma­tion on dara­tu­mu­mab, please see the Summary of Product Characteristics at https://www.ema.europa.eu/documents/product-information/darzalex-epar-product-information_en.pdf.

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a world­wide agree­ment, which granted Janssen an exclusive licence to develop, manu­fac­ture and commercialise dara­tu­mu­mab.15

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.¹⁶ More than 45,000 people were diag­nosed with multiple myeloma in Europe in 2016, and more than 29,000 patients died.¹⁷ Up to half of newly diag­nosed patients do not reach five-year survival,¹⁸ and almost 29% of patients with multiple myeloma will die within one year of diag­nosis.¹⁹

Although treat­ment may result in remission, unfortunately, patients will most likely relapse as there is cur­rently no cure.²⁰ Refractory multiple myeloma is when a patient’s disease progresses within 60 days of their last ther­apy.^21,22 Relapsed cancer is when the disease has returned after a period of initial, partial or com­plete remission.²³ While some patients with MM have no symp­toms at all, most patients are diag­nosed due to symp­toms that can in­clude bone problems, low blood counts, cal­cium elevation, kidney problems or in­fec­tions.²⁴ Patients who relapse after treat­ment with standard ther­a­pies, in­­clud­ing PIs and immuno­modu­la­tory agents, have poor prognoses and few treat­ment options avail­able.²⁵

About the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson

At the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson, we are work­ing to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease in­spires us. We bring together the best minds and pursue the most promising science. We are Janssen. We col­lab­o­rate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA for our latest news.

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

Cautions Concerning Forward-Looking Statements

This press release con­tains "forward-looking state­ments" as defined in the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 re­gard­ing a recom­men­da­tion to broaden the existing mar­ket­ing authori­sa­tion for dara­tu­mu­mab. 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 ma­teri­alise, actual results could vary ma­teri­ally from the ex­pec­ta­tions and projections of Janssen-Cilag Inter­na­tional NV, Janssen-Cilag Limited, Janssen Biotech, Inc., any of the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson and/or Johnson & Johnson. Risks and un­cer­tain­ties in­clude, but are not limited to: chal­lenges and un­cer­tain­ties in­her­ent in prod­uct research and devel­op­ment, in­­clud­ing the uncertainty of clin­i­cal success and of obtaining regu­la­tory approvals; uncertainty of commercial success; manu­fac­tur­ing dif­fi­culties and delays; 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 of purchasers of health care prod­ucts and services; changes to appli­­cable laws and reg­u­la­tions, in­­clud­ing global health care reforms; and trends to­ward health care cost con­tainment. A further list and descriptions 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 31, 2017, in­­clud­ing in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the com­pany’s most recently filed Quarterly Report on Form 10-Q and in 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. Neither the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson nor 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.