• DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients
• Today's FDA approval of DARZALEX® in com­bi­na­tion with bortez­o­mib, mel­phalan and pred­ni­sone marks its fifth indi­ca­tion in multiple myeloma

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson an­nounced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved DARZALEX® (dara­tu­mu­mab) in combi­na­tion with VELCADE® (bor­tez­o­mib)*, a pro­teasome inhibitor (PI); mel­phalan, an alkylat­ing agent; and pred­ni­sone – VMP – for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for autol­o­gous stem cell trans­plant (ASCT). DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients with this disease. Clinical trial results showed DARZALEX® in combi­na­tion with VMP reduced the risk of disease pro­gression or death by 50 per­cent com­pared to treat­ment with VMP alone.¹

"This approval is sig­nif­i­cant as we now have the first anti­body-based regi­men for treating newly diag­nosed multiple myeloma patients who are not eli­gible for a stem cell trans­plant," said Andrzej Jakubowiak, M.D., Ph.D., Director of the Multiple Myeloma Program at University of Chicago Medical Center, Chicago, Illinois and a DARZLAEX® clin­i­cal study investi­gator. "In clin­i­cal studies, patients who received treat­ment with dara­tu­mu­mab ex­peri­enced a lower risk of disease pro­gression and higher rates of response."

The FDA approval of DARZALEX® in combi­na­tion with VMP is sup­ported by data from the ran­domized, open-label, multi­center Phase 3 ALCYONE (MMY3007) study, recently published in the New England Journal of Medicine. The combi­na­tion of DARZALEX® with VMP reduced the risk of disease pro­gres­sion or death by 50 per­cent, com­pared to treat­ment with VMP alone (Hazard Ratio [HR] = 0.50; 95 per­cent CI [0.38-0.65], p<0.0001).¹ The median pro­gres­sion-free survival (PFS) for DARZALEX®-VMP had not yet been reached, com­pared to a median PFS of 18.1 months for patients who received VMP alone.¹

"A patient's best chance at lasting remission often begins with a durable response to frontline ther­apy, because multiple myeloma can be­come more dif­fi­cult to treat after relapse," said Maria-Victoria Mateos, M.D., Ph.D., Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL, Salamanca, Spain and ALCYONE pri­mary investigator. "combi­na­tion ther­apy with dara­tu­mu­mab resulted in deep and durable responses in newly diag­nosed patients with multiple myeloma who are trans­plant in­eli­gible, sup­porting this regi­men as an im­por­tant new treat­ment option for these patients."

Treatment with DARZALEX® in combi­na­tion with VMP sig­nif­i­cantly im­proved over­all response rates (91 vs. 74 per­cent) com­pared to VMP alone.¹ Additionally, measures of stringent com­plete response (18 vs. 7 per­cent), com­plete response or better (43 vs. 24 per­cent) and very good partial response or better (71 vs. 50 per­cent) all showed marked im­prove­ment.¹ Patients receiving DARZALEX® in combi­na­tion with VMP achieved a more than three-fold in­­crease in the minimal residual disease (MRD) negativity rate (22 vs. 6 per­cent) com­pared to those who received VMP alone.¹

In the ALYCONE study, the most frequent adverse reac­tions (>20 per­cent) with at least 5 per­cent greater frequency in the DARZALEX®-VMP arm were upper res­pira­tory tract in­fec­tion (48 vs. 28 per­cent), in­fusion reac­tions (28 vs. 0 per­cent) and periph­eral edema (21 vs. 14 per­cent).¹ Serious adverse reac­tions with at least a 2 per­cent greater in­ci­dence in the DARZALEX®-VMP arm vs. VMP were pneu­monia (11 vs. 4 per­cent), upper res­pira­tory tract in­fec­tion (5 vs.1 per­cent) and pul­mo­nary edema (2 vs. 0 per­cent).¹ The most common Grade 3/4 treat­ment-emergent hematology laboratory ab­nor­mal­i­ties for DARZALEX®-VMP vs. VMP were lympho­penia (58 vs. 53 per­cent), neutro­penia (44 vs. 43 per­cent) and thrombo­cytopenia (38 vs. 42 per­cent).¹ The warnings and precautions for DARZALEX® in­clude in­fusion reac­tions, inter­ference with cross-matching and red blood cell anti­body screen­ing, neutro­penia and thrombo­cyto­penia (see Important Safety Information).¹

"Slowing the pro­gres­sion of myeloma translates to more time in remission for those battling the disease. This latest approval for DARZALEX® in combi­na­tion with VMP is an exciting step for­ward for newly diag­nosed patients and the health­care teams who treat them," said Paul Giusti, Pres­i­dent and CEO of the Multiple Myeloma Research Foundation (MMRF). "The MMRF congratulates Janssen, our long-time col­lab­o­rator in myeloma research, the dedicated health­care providers in the myeloma com­munity as well as the patients who donate their time and data on clin­i­cal trials, for making this critical new combi­na­tion ther­apy possible."

Today's FDA approval marks the fifth indi­ca­tion for DARZALEX®, the first CD38-directed anti­body approved any­where in the world and the first anti­body approved for newly diag­nosed patients with multiple myeloma who are trans­plant in­eligible.¹ DARZALEX® was first approved by the FDA in November 2015 as a mono­therapy for patients with multiple myeloma who have received at least three prior lines of ther­apy, in­­clud­ing a PI and an immuno­modu­latory agent, or who are double refractory to a PI and an immuno­modu­latory agent.² DARZALEX® received addi­tional approvals in November 2016 in combi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy.³ In June 2017, DARZALEX® received approval in combi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a PI.⁴

"We are grateful to the patients and physicians who par­tic­i­pated in the clin­i­cal pro­gram that enabled today's im­por­tant approval of DARZALEX® combi­na­tion ther­apy as a treat­ment option for newly diag­nosed patients with multiple myeloma who are trans­plant in­eli­gible," said Peter Lebowitz, M.D., Ph.D, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "DARZALEX® has redefined how we ap­proach the treat­ment of multiple myeloma, and we con­tinue to eval­u­ate its poten­tial in combi­na­tion with other regi­mens, with the aim of arresting the disease at its earliest stages."

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a world­wide agree­ment, which granted Janssen an exclusive license to develop, manu­fac­ture and com­mer­cial­ize DARZALEX®.5 Janssen Biotech, Inc. com­mer­cial­izes DARZALEX® in the U.S. For full Prescribing Information, please visit www.DARZALEX.com.

About DARZALEX® (dara­tu­mu­mab) Injection, for Intravenous Infusion

DARZALEX® (dara­tu­mu­mab) injection for in­tra­venous use is the first CD38-directed anti­body approved any­where in the world.¹ CD38 is a surface protein that is highly ex­pressed across multiple myeloma cells, re­gard­less of disease stage.6 DARZALEX® is believed to induce tumor 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.¹ Subsets of myeloid derived sup­pressor cells (MDSCs), CD38+ regu­la­tory T cells (Tregs) and CD38+ B cells (Bregs) were de­creased by DARZALEX®.¹ DARZALEX® is being eval­u­ated in a com­pre­hen­sive clin­i­cal devel­op­ment pro­gram across a range of treat­ment settings in multiple myeloma, such as in frontline and re­lapsed settings.^{7,8,9,10,11,12,13,14} Additional studies are ongoing or planned to assess its poten­tial in other malignant and pre-malignant hema­to­logic diseases in which CD38 is ex­pressed, such as smol­der­ing myeloma, as well as in solid tumors.^15,16,17 DARZALEX® is the first and only CD38-directed anti­body to receive regu­la­tory approval to treat multiple myeloma.¹

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow un­con­trol­lably in the bone marrow.^18,19 Refractory cancer occurs when a patient's disease is resistant to treat­ment or in the case of multiple myeloma, patients progress within 60 days of their last ther­apy.^20,21 Relapsed cancer means the disease has returned after a period of initial, partial or com­plete remission.²² In 2018, it is esti­mated that 30,700 people will be diag­nosed and 12,770 will die from the disease in the United States.²³ While some patients with multiple myeloma have no symp­toms at all, most patients are diag­nosed due to symp­toms, which can in­clude bone fracture or pain, low red blood counts, fatigue, cal­cium elevation, kidney problems or in­fec­tions.²⁴

IMPORTANT SAFETY INFORMATION¹

CONTRAINDICATIONS - None

WARNINGS AND PRECAUTIONS

Infusion Reactions – DARZALEX can cause severe in­fusion reac­tions. Approxi­mately half of all patients ex­peri­enced a reac­tion, most during the first in­fusion. Infusion reac­tions can also occur with sub­sequent in­fusions. Nearly all reac­tions occurred during in­fusion or within 4 hours of com­plet­ing an in­fusion. Prior to the in­tro­duc­tion of post-infusion medication in clin­i­cal trials, in­fusion reac­tions occurred up to 48 hours after in­fusion. Severe reac­tions have occurred, in­­clud­ing bron­cho­spasm, hypoxia, dyspnea, hyper­tension, laryngeal edema and pul­mo­nary edema. Signs and symp­toms may in­clude res­pira­tory symp­toms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting and nausea. Less common symp­toms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypo­­tension.

Pre-medicate patients with antihistamines, anti­pyretics, and corticosteroids. Frequently monitor patients during the entire in­fusion. Interrupt in­fusion for reac­tions of any severity and institute medical man­age­ment as needed. Permanently dis­con­tinue ther­apy for life-threatening (Grade 4) reac­tions. For patients with Grade 1, 2, or 3 reac­tions, reduce the in­fusion rate when re-starting the in­fusion.

To reduce the risk of delayed in­fusion reac­tions, admin­ister oral cortico­steroids to all patients fol­low­ing DARZALEX in­fusions. Patients with a history of chronic obstructive pul­mo­nary disease may require addi­tional post-infusion medications to man­age res­pira­tory com­pli­ca­tions. Consider pre­scrib­ing short- and long-acting broncho­dilators and inhaled cortico­steroids for patients with chronic obstructive pul­mo­nary disease.

Interference with Serological Testing - Dara­tu­mu­mab binds to CD38 on red blood cells (RBCs) and results in a pos­i­tive Indirect Antiglobulin Test (Indirect Coombs test). Dara­tu­mu­mab-mediated pos­i­tive indirect antiglobulin test may persist for up to 6 months after the last dara­tu­mu­mab in­fusion. Dara­tu­mu­mab bound to RBCs masks detection of anti­bodies to minor an­ti­gens in the patient's serum. The deter­mi­na­tion of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this inter­fer­ence with serological testing and inform blood banks that a patient has received DARZALEX. Type and screen patients prior to starting DARZALEX.

Neutropenia - DARZALEX may in­­crease neu­tro­penia induced by back­ground ther­apy. Monitor com­plete blood cell counts periodically during treat­ment according to manu­­fac­­turer's pre­scribing in­­for­ma­tion for back­ground ther­a­pies. Monitor patients with neu­tro­penia for signs of in­fec­tion. DARZALEX dose delay may be required to allow re­cov­ery of neu­tro­phils. No dose reduction of DARZALEX is rec­om­mended. Consider sup­port­ive care with growth factors.

Thrombocytopenia - DARZALEX may in­­crease thrombo­cytopenia induced by back­ground ther­apy. Monitor com­plete blood cell counts periodically during treat­ment according to manu­­fac­­turer's pre­scribing in­­for­ma­tion for back­ground ther­a­pies. DARZALEX dose delay may be required to allow re­cov­ery of platelets. No dose reduction of DARZALEX is rec­om­mended. Consider sup­port­ive care with transfusions.

Interference with Determination of Complete Response - Dara­tu­mu­mab is a human IgG kappa mono­clonal anti­body that can be detected on both, the serum protein electro­phoresis (SPE) and immuno­fix­a­tion (IFE) assays used for the clin­i­cal monitoring of endogenous M-protein. This inter­ference can impact the determina­tion of com­plete response and of disease pro­gression in some patients with IgG kappa myeloma protein.

Adverse Reactions

In patients who received DARZALEX® in combi­na­tion with bor­tez­o­mib, mel­phalan, and pred­ni­sone, the most frequently reported adverse reac­tions (incidence ≥20%) were: upper res­pira­tory tract in­fec­tion (48%), in­fusion reac­tions (28%), and periph­eral edema (21%). Serious adverse reac­tions (≥2% greater com­pared to the VMP arm) were pneu­monia (11%), upper res­pira­tory tract in­fec­tion (5%), and pul­mo­nary edema (2%). Treatment emergent grade 3-4 hematology laboratory ab­nor­mal­i­ties ≥20% were thrombo­cytopenia (38%), neu­tro­penia (44%), and lymphopenia (58%).

In patients who received DARZALEX in combi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, the most frequently reported adverse reac­tions (incidence ≥20%) were: thrombo­cyto­penia (90%), neu­tro­penia (58%), periph­eral sensory neu­rop­athy (47%), in­fusion reac­tions (45%), upper res­pira­tory tract in­fec­tion (44%), diarrhea (32%), cough (27%), periph­eral edema (22%), and dyspnea (21%). The over­all in­ci­dence of serious adverse reac­tions was 42%. Serious adverse reac­tions were upper res­pira­tory tract in­fec­tion (5%), diarrhea (2%) and atrial fibrillation (2%).

In patients who received DARZALEX as mono­therapy, the most frequently reported adverse reac­tions (incidence ≥20%) were: neutro­penia (60%), thrombo­cyto­penia (48%), in­fusion reac­tions (48%), fatigue (39%), nausea (27%), back pain (23%), pyrexia (21%), cough (21%), and upper res­pira­tory tract in­fec­tion (20%). Serious adverse reac­tions were reported in 51 (33%) patients. The most frequent serious adverse reac­tions were pneu­monia (6%), general physical health deterioration (3%), and pyrexia (3%).

In patients who received DARZALEX in combi­na­tion with poma­lido­mide and dexa­meth­a­sone, the most frequent adverse reac­tions (≥20%) were in­fusion reac­tions (50%), diarrhea (38%), con­sti­pa­tion (33%), nausea (30%), vomiting (21%), fatigue (50%), pyrexia (25%), upper res­pira­tory tract in­fec­tion (50%), muscle spasms (26%), back pain (25%), arthralgia (22%), dizzi­ness (21%), insomnia (23%), cough (43%) and dyspnea (33%). The over­all in­ci­dence of serious adverse reac­tions was 49%. Serious adverse reac­tions reported in ≥5% patients in­cluded pneu­monia (7%).

DRUG INTERACTIONS

Effect of Other Drugs on dara­tu­mu­mab: The coadministration of lena­lido­mide, poma­lido­mide or bor­tez­o­mib with DARZALEX did not affect the phar­ma­co­ki­netics of dara­tu­mu­mab.

Effect of Dara­tu­mu­mab on Other Drugs: The coadministration of DARZALEX with bor­tez­o­mib or poma­lido­mide did not affect the phar­ma­co­ki­netics of bor­tez­o­mib.

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. Follow us at @JanssenGlobal and @JanssenUS. Janssen Research & Development, LLC is part of the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson.

*VELCADE® (bor­tez­o­mib) is a registered trademark of Millennium Pharma­ceu­ticals, Inc.

This press release con­tains "forward-looking state­ments" as defined in the Private Securi­ties Litiga­tion Reform Act of 1995 re­gard­ing the benefits of DARZALEX® (dara­tu­mu­mab) for the treat­ment of patients with multiple myeloma. 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 the Janssen Pharma­ceutical Com­panies of Johnson & Johnson and/or Johnson & Johnson. Risks and un­cer­tain­ties in­clude, but are not limited to: uncertainty of com­mercial success; chal­lenges to patents; com­pe­ti­tion, in­­clud­ing tech­nological ad­vances, new prod­ucts and patents attained by competi­tors; manu­facturing dif­fi­culties and delays; prod­uct efficacy or safety con­cerns resulting in prod­uct recalls or regu­la­tory action; changes to appli­­cable laws and reg­u­la­tions, in­­clud­ing global health care reforms; changes in behavior and spending patterns of purchasers of health care prod­ucts and services; 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," and in the com­pany's sub­se­quent Quarterly Reports on Form 10-Q and other 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.

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Source: Janssen.