Application sup­ported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot pro­gram

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

The sBLA, based upon data from the Phase 3 MAIA (MMY3008) clin­i­cal study, is being reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot pro­gram, which for certain appli­ca­tions allows the FDA to review data before the applicant formally submits the com­plete appli­ca­tion. It aims to explore a more efficient review process to help ensure treat­ments are avail­able as soon as possible for patients. Selection into the RTOR pilot pro­gram does not guar­an­tee or influence approvability of the supple­mental appli­ca­tion.

"We are pleased to com­plete the latest DARZALEX sub­mission based upon the Phase 3 MAIA study, which eval­u­ated the efficacy and safety of this anti-CD38 mono­clonal anti­body as a com­bi­na­tion regi­men for newly diag­nosed patients with multiple myeloma who are trans­plant in­eli­gible," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Vice Pres­i­dent, Hematologic Malignancies Disease Area Leader, Janssen Research & Development, LLC. "We look for­ward to closely col­lab­o­rating with the Agency through­out the expedited Real-Time Oncology Review process in sup­port of this newly diag­nosed, trans­plant in­eli­gible multiple myeloma patient pop­u­la­tion for whom a com­bi­na­tion treat­ment regi­men with DARZALEX may be useful."

Data from the Phase 3 MAIA study were presented at the 2018 American Society of Hematology (ASH) Annual Meeting and featured in the Late-Breaking Abstract session. The study found that at a median follow-up of 28 months, DARZALEX-Rd reduced the risk of disease pro­gres­sion or death by 44 per­cent in patients with newly diag­nosed multiple myeloma who are trans­plant in­eli­gible com­pared to treat­ment with Rd alone (Hazard Ratio [HR] = 0.56; 95 per­cent con­fi­dence in­ter­val [CI]: 0.43-0.73; p<0.0001).¹ The median pro­gres­sion-free survival for DARZALEX-Rd has not yet been reached, com­pared to 31.9 months for patients who received Rd alone.¹ The addi­tion of DARZALEX resulted in deeper responses com­pared to Rd alone, in­­clud­ing in­­creased rates of com­plete response or better (48 per­cent vs. 25 per­cent).1 An im­proved over­all response rate was also dem­onstrated (93 per­cent vs. 81 per­cent).¹

The most common Grade 3/4 treat­ment-emergent adverse events for DARZALEX-Rd (≥10 per­cent) in­cluded neu­tro­penia (50 per­cent), lymphopenia (15 per­cent), pneu­monia (14 per­cent) and anemia (12 per­cent).¹ Infusion-related reac­tions occurred in 41 per­cent of patients, three per­cent of which were Grade 3/4.¹ The safety profile of DARZALEX was con­sis­tent with that of pre­vi­ous studies.¹

About the Real-Time Oncology Review Program

The RTOR pilot pro­gram aims to explore a more efficient review process to ensure safe and effective treat­ments be­come avail­able to patients earlier while main­taining the quality of review. Applications are subject to the usual benefit-risk evaluation by FDA scientists. The RTOR pilot pro­gram is specific to the U.S. regu­la­tory path­way.

About the MAIA Trial¹

The ran­dom­ized, open-label, multi­center, Phase 3 study in­cluded 737 newly diag­nosed patients with multiple myeloma in­eli­gible for high-dose chemo­ther­apy and ASCT aged 45 – 90 years old (median age of 73). Patients were ran­dom­ized to receive either DARZALEX-Rd or Rd alone in 28-day Cycles. In the DARZALEX-Rd treat­ment arm, patients received DARZALEX 16 milligrams per kilo­gram (mg/kg) IV weekly for Cycles 1 – 2, every two weeks for Cycles 3 – 6 and every 4 weeks for Cycle 7 and there­after. Patients in the DARZALEX-Rd and Rd treat­ment arm received 25 mg of lena­lido­mide on Days 1 – 21 of each 28-day Cycle, and dexa­meth­a­sone at 40 mg once a week for each Cycle. Patients in both treat­ment arms con­tinued until disease pro­gres­sion or unacceptable toxicity.

About DARZALEX® (dara­tu­mu­mab)

DARZALEX® (dara­tu­mu­mab), the first CD38-directed anti­body approved any­where in the world, is the only CD38-directed anti­body approved to treat multiple myeloma.² CD38 is a surface protein that is present in high numbers on multiple myeloma cells, re­gard­less of the stage of disease.³ DARZALEX binds to CD38 and inhibits tumor cell growth causing myeloma cell death.2 DARZALEX may also have an effect on nor­mal cells.² 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.^{4,5,6,7,8,9,10,11} 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.^12,13

In the U.S., DARZALEX received initial FDA approval in November 2015 as a mono­therapy for patients with multiple myeloma who have received at least three prior lines of ther­apy, in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent, or who are double refractory to a PI and an immuno­modu­la­tory agent.¹⁴ 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.¹⁵ 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.¹⁶ Most recently, in May 2018, DARZALEX received approval in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for ASCT, making it the first mono­clonal anti­body approved for newly diag­nosed patients with this disease.¹⁷

In August 2012, Janssen Biotech, Inc. entered into a global license and devel­op­ment agree­ment with Genmab A/S, which granted Janssen an exclusive license to develop, manu­fac­ture and com­mer­cial­ize DARZALEX.¹⁸ For the full U.S. Prescribing Information, please visit www.DARZALEX.com.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.^19,20 When damaged, these plasma cells rapidly spread and replace nor­mal cells with tumors in the bone marrow.^19,20 In 2019, it is esti­mated that 32,110 people will be diag­nosed, and 12,960 will die from the disease, in the U.S.²¹ While some patients with multiple myeloma have no symp­toms, most patients are diag­nosed due to symp­toms, which can in­clude bone fracture or pain, low red blood counts, tiredness, high cal­cium levels, kidney problems or in­fec­tions.²²

IMPORTANT SAFETY INFORMATION²

CONTRAINDICATIONS

DARZALEX® is con­tra­in­di­cated in patients with a history of severe hypersensitivity (e.g., anaphylactic reac­tions) to dara­tu­mu­mab or any of the components of the for­mu­la­tion.

WARNINGS AND PRECAUTIONS

Infusion Reactions – DARZALEX® can cause severe and/or serious in­fusion reac­tions, in­­clud­ing anaphylactic reac­tions. In clin­i­cal trials, approx­i­mately half of all patients ex­peri­enced an in­fusion reac­tion. Most in­fusion reac­tions occurred during the first in­fusion and were grade 1-2. 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 if an anaphylactic reac­tion or life-threatening (Grade 4) reac­tion occurs and institute appro­pri­ate emergency care. 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 – The most frequently reported adverse reac­tions (incidence ≥20%) in clin­i­cal trials were: in­fusion reac­tions, neu­tro­penia, thrombo­cyto­penia, fatigue, nausea, diarrhea, con­sti­pa­tion, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizzi­ness, insomnia, cough, dyspnea, periph­eral edema, periph­eral sensory neu­rop­athy and upper res­pira­tory tract in­fec­tion.

In patients who received DARZALEX® in com­bi­na­tion with bor­tez­o­mib, mel­phalan, and pred­ni­sone (DVMP), 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% 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 lymphopenia (58%), neu­tro­penia (44%), and thrombo­cyto­penia (38%).

In patients who received DARZALEX® in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, the most frequently reported adverse reac­tions (incidence ≥20%) were: upper res­pira­tory tract in­fec­tion (65%), in­fusion reac­tions (48%), diarrhea (43%), fatigue (35%), cough (30%), muscle spasms (26%), nausea (24%), dyspnea (21%) and pyrexia (20%). The over­all in­ci­dence of serious adverse reac­tions was 49%. Serious adverse reac­tions (≥2% com­pared to Rd) were pneu­monia (12%), upper res­pira­tory tract in­fec­tion (7%), influenza (3%), and pyrexia (3%). Treatment-emergent Grade 3-4 hematology laboratory ab­nor­mal­i­ties ≥20% were neu­tro­penia (53%) and lymphopenia (52%).

In patients who received DARZALEX® in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, the most frequently reported adverse reac­tions (incidence ≥20%) were: 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 (≥2% com­pared to Vd) were upper res­pira­tory tract in­fec­tion (5%), diarrhea (2%) and atrial fibrillation (2%). Treatment-emergent Grade 3-4 hematology laboratory ab­nor­mal­i­ties ≥20% were lymphopenia (48%) and thrombo­cyto­penia (47%).

In patients who received DARZALEX® in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone, the most frequent adverse reac­tions (>20%) were fatigue (50%), in­fusion reac­tions (50%), upper res­pira­tory tract in­fec­tion (50%), cough (43%), diarrhea (38%), con­sti­pa­tion (33%), dyspnea (33%), nausea (30%), muscle spasms (26%), back pain (25%), pyrexia (25%), insomnia (23%), arthralgia (22%), dizzi­ness (21%), and vomiting (21%). The over­all in­ci­dence of serious adverse reac­tions was 49%. Serious adverse reac­tions reported in ≥5% patients in­cluded pneu­monia (7%). Treatment-emergent hematology Grade 3-4 laboratory ab­nor­mal­i­ties ≥20% were anemia (30%), neu­tro­penia (82%), and lymphopenia (71%).

In patients who received DARZALEX® as mono­therapy, the most frequently reported adverse reac­tions (incidence ≥20%) were: in­fusion reac­tions (48%), fatigue (39%), nausea (27%), back pain (23%), pyrexia (21%), cough (21%), and upper res­pira­tory tract in­fec­tion (20%). The over­all in­ci­dence of serious adverse reac­tions was 33%. The most frequent serious adverse reac­tions were pneu­monia (6%), general physical health deterioration (3%), and pyrexia (3%). Treatment-emergent Grade 3-4 hematology laboratory ab­nor­mal­i­ties ≥20% were lymphopenia (40%) and neu­tro­penia (20%).

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 or poma­lido­mide.

About the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharma­ceu­tical Com­panies of Johnson & Johnson, work­ing tirelessly to make that future a reality for patients every­where by fighting sickness with science, im­prov­ing access with ingenuity, and heal­ing hope­less­ness with heart. We focus on areas of med­i­cine where we can make the biggest dif­fer­ence: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are members 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 the devel­op­ment of DARZALEX. 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 Janssen Research & Development, LLC, any of the other Janssen Pharma­ceu­tical Com­panies 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 behavior 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 30, 2018, in­­clud­ing in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the com­pany's most recently filed Quarterly Report on Form 10-Q, 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 nor Johnson & Johnson under­takes to update any for­ward-looking state­ment as a result of new in­for­ma­tion or future events or devel­op­ments.

References

1. Clinicaltrials.gov. Study Comparing Dara­tu­mu­mab, Lenalidomide, and Dexamethasone with Lenalidomide and Dexamethasone in Participants with Previously Untreated Multiple Myeloma. https://clinicaltrials.gov/ct2/show/NCT02252172. Accessed March 2019.
2. DARZALEX Prescribing Information, June 2018.
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9. Janssen Research & Development, LLC. A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Dara­tu­mu­mab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812?term=MMY3011&rank=1 Identifier: NCT03217812.
10. European Myeloma Network. Compare Progression Free Survival Btw Dara­tu­mu­mab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03180736?term=MMY3013&rank=2 Identifier: NCT03180736
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12. Janssen Research & Development, LLC. A Study to Evaluate 3 Dose Schedules of Dara­tu­mu­mab in Participants With Smoldering Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02316106?term=smm2001&rank=1 Identifier: NCT02316106.
13. Janssen Research & Development, LLC. An Efficacy and Safety Proof of Concept Study of Dara­tu­mu­mab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02413489?term=lym2001&rank=1 Identifier: NCT02413489
14. Janssen Biotech, Inc. "DARZALEX® (dara­tu­mu­mab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma." Issued November 16, 2015.
15. Janssen Biotech, Inc. "DARZALEX® (dara­tu­mu­mab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy." Issued November 21, 2016.
16. Janssen Biotech, Inc. "DARZALEX® (dara­tu­mu­mab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies." Issued June 16, 2017.
17. Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson. "Janssen Announces DARZALEX® (dara­tu­mu­mab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible." Issued May 7, 2018.
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Source: Janssen.