Applications sup­ported by pos­i­tive re­sults from the Phase 3 APOLLO study, which dem­onstrated longer pro­gres­sion-free sur­vival in patients re­ceiv­ing the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab¹

RARITAN, N.J., Nov. 12, 2020 /PRNewswire/ -- The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the sub­mission of regu­la­tory appli­ca­tions to the U.S. Food and Drug Admin­istra­tion (FDA) and Euro­pean Medicines Agency (EMA) seek­ing ap­prov­al of the dara­tu­mu­mab sub­cu­tane­ous (SC) for­mu­la­tion, known as DAR­ZA­LEX FASPRO™ (dara­tu­mu­mab and hyal­uron­i­dase-fihj) in the U.S. and as DAR­ZA­LEX® SC in the Euro­pean Union (EU). The appli­ca­tions seek ap­prov­al of the com­bi­na­tion of DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (D-Pd) for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least one prior line of ther­apy. As a fixed-dose for­mu­la­tion, DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC can be admin­istered over approx­i­mately three to five min­utes, sig­nif­i­cantly less time than the in­tra­venous (IV) for­mu­la­tion of DAR­ZA­LEX®, which is given over sev­er­al hours.

The supple­mental Biologics License Appli­ca­tion (sBLA) to the U.S. FDA and Type II variation appli­ca­tion to the EMA are sup­ported by pos­i­tive find­ings from the Phase 3 APOLLO study (MMY3013), which met its pri­mary end­point of sig­nif­i­cantly longer pro­gres­sion-free sur­vival (PFS) in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who re­ceived D-Pd com­pared with Pd alone.²

Full re­sults from the Phase 3 APOLLO study, a col­lab­o­ration be­tween Janssen Re­search & De­vel­op­ment, LLC and the Euro­pean Myeloma Network (EMN), will be pre­sented in an oral session at the up­com­ing American Society of He­ma­tol­ogy (ASH) Annual Meeting on Sunday, De­cem­ber 6, 2020 at 3:00 p.m. ET (Abstract #412).

The D-Pd regi­men re­ceived ap­prov­al from the U.S. FDA for the IV for­mu­la­tion of DAR­ZA­LEX® in 2017 for patients who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.³ This regi­men for the IV for­mu­la­tion is not ap­prov­ed for use in Europe by the EMA.

"The IV for­mu­la­tion of DAR­ZA­LEX, which is ap­prov­ed in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone, is an im­por­tant op­tion for patients with mul­ti­ple myeloma. We are ex­cited to pur­sue the sub­cu­tane­ous for­mu­la­tion of DAR­ZA­LEX for this in­di­ca­tion as we look to re­duce admin­istra­tion time from hours to min­utes com­pared with the IV for­mu­la­tion," said Craig Tendler, M.D., Vice Pres­i­dent, Late De­vel­op­ment and Global Medical Affairs, On­col­ogy, Janssen Re­search & De­vel­op­ment, LLC. "Today's regu­la­tory mile­stones rep­re­sent our con­tinued com­mitment to ad­vance inno­va­tive treat­ments for people living with mul­ti­ple myeloma."

DARZALEX® was first ap­prov­ed as a mono­therapy for the treat­ment of mul­ti­ple myeloma in 2015 in the U.S. and in 2016 in the EU, making it the first anti-CD38 mono­clonal anti­body ap­prov­ed any­where in the world for mul­ti­ple myeloma.^3,4 In 2020, DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC was ap­prov­ed by the U.S. FDA and the Euro­pean Com­mis­sion (EC) as the only CD38-directed anti­body ap­prov­ed to be given sub­cu­tane­ously to treat patients with mul­ti­ple myeloma.^5,6 DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC is co-formulated with recombinant human hyal­uron­i­dase PH20 (rHuPH20), Halozyme's ENHANZE® drug de­livery tech­nology. As of 2020, dara­tu­mu­mab has been ap­prov­ed by global regu­la­tory author­i­ties across six com­bi­na­tion regi­mens and as a mono­therapy for the treat­ment of newly diag­nosed patients, across re­lapsed and re­frac­tory mul­ti­ple myeloma.^{9,10,11,12,13,14}

"Despite strong progress in mul­ti­ple myeloma over the last decade, it re­mains a dis­ease with sig­nif­i­cant unmet need," said Catherine Taylor, M.D., Vice Pres­i­dent, Medical Affairs Thera­peutic Area Strategy, Europe, Middle East and Africa (EMEA), John­son & John­son Middle East FZ-LLC. "We are pleased to pur­sue this im­por­tant DAR­ZA­LEX-based com­bi­na­tion regi­men, which was in the first study showing a sig­nif­i­cant in­crease in pro­gres­sion-free sur­vival of a sub­cu­tane­ous anti-CD38 in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone in patients with pre­vi­ously treated mul­ti­ple myeloma."

About the APOLLO Study¹

APOLLO (NCT01960348) is an on­go­ing multi­center, Phase 3, ran­dom­ized, open-label study com­par­ing DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone with poma­lido­mide and low-dose dexa­meth­a­sone alone in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least one prior treat­ment regi­men, have re­ceived both lena­lido­mide and a pro­te­a­some in­hib­i­tor, and have dem­onstrated dis­ease pro­gres­sion. The study en­rolled 304 par­tic­i­pants. The pri­mary end­point is PFS be­tween treat­ment arms. Secondary end­points in­clude rates of over­all re­sponse (ORR), very good partial re­sponse (VGPR) or better, com­plete re­sponse (CR) or better, and duration of re­sponse.

About DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC

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 dara­tu­mu­mab. Since launch, it is esti­mated that more than 154,000 patients have been treated with dara­tu­mu­mab world­wide.7 DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC is the only CD38-directed anti­body ap­prov­ed to be given sub­cu­tane­ously to treat patients with mul­ti­ple myeloma.

CD38 is a surface pro­tein that is present in high num­bers on mul­ti­ple myeloma cells, re­gard­less of the stage of dis­ease.9 Dara­tu­mu­mab binds to CD38 and in­hib­its tumor cell growth, causing myeloma cell death.8 Dara­tu­mu­mab may also have an effect on nor­mal cells.9 Data across seven Phase 3 clin­i­cal trials, in both the front­line and re­lapsed settings, have shown that dara­tu­mu­mab-based regi­mens re­sulted in sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival and/or over­all sur­vival.^{10,11,12,13,14,15,16,17} Addi­tional stud­ies are underway to assess the ef­fi­cacy and safety of DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC in the treat­ment of other malignant and pre-malignant hema­to­logic dis­eases in which CD38 is ex­pressed, in­clud­ing smol­der­ing myeloma and light chain (AL) amy­loid­osis.^18,19

For the full U.S. Prescribing In­for­ma­tion, please visit www.DARZALEX.com. For the full EU Summary of Product Characteristics, please click here.

DARZALEX FASPRO™ IMPORTANT SAFETY INFORMATION (US)

CONTRAINDICATIONS

DARZALEX FASPRO™ is con­tra­in­di­cated in patients with a history of severe hypersensitivity to dara­tu­mu­mab, hyal­uron­i­dase or any of the components of the for­mu­la­tion.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Other Admin­istra­tion Reactions

Both sys­temic admin­istra­tion-related re­ac­tions, in­clud­ing severe or life-threatening re­ac­tions, and local in­jec­tion-site re­ac­tions can oc­cur with DAR­ZA­LEX FASPRO™.

Systemic Reactions

In a pooled safety pop­u­la­tion of 490 patients who re­ceived DAR­ZA­LEX FASPRO™ as mono­therapy or in com­bi­na­tion, 11% of patients ex­peri­enced a sys­temic admin­istra­tion-related re­ac­tion (Grade 2: 3.9%, Grade 3: 1.4%). Systemic admin­istra­tion-related re­ac­tions oc­curred in 10% of patients with the first in­jec­tion, 0.2% with the sec­ond in­jec­tion, and cumulatively 0.8% with sub­se­quent in­jec­tions. The median time to onset was 3.7 hours (range: 9 min­utes to 3.5 days). Of the 84 sys­temic admin­istra­tion-related re­ac­tions that oc­curred in 52 patients, 73 (87%) oc­curred on the day of DAR­ZA­LEX FASPRO™ admin­istra­tion. Delayed sys­temic admin­istra­tion-related re­ac­tions have oc­curred in less than 1% of the patients.

Severe re­ac­tions in­cluded hypoxia, dyspnea, hyper­tension and tachycardia. Other signs and symp­toms of sys­temic admin­istra­tion-related re­ac­tions may in­clude res­pira­tory symp­toms, such as bron­cho­spasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as ana­phy­lactic re­ac­tion, pyrexia, chest pain, pruritis, chills, vomiting, nausea, and hypo­tension.

Pre-medicate patients with his­ta­mine-1 re­cep­tor antagonist, acet­amin­o­phen and cortico­steroids. Monitor patients for sys­temic admin­istra­tion-related re­ac­tions, especially fol­low­ing the first and sec­ond in­jec­tions. For ana­phy­lactic re­ac­tion or life-threatening (Grade 4) admin­istra­tion-related re­ac­tions, im­medi­ately and per­ma­nently dis­con­tinue DAR­ZA­LEX FASPRO™. Consider admin­istering cortico­steroids and other med­i­ca­tions after the admin­istra­tion of DAR­ZA­LEX FASPRO™ de­pending on dosing regi­men and med­i­cal history to minimize the risk of delayed (defined as oc­curring the day after admin­istra­tion) sys­temic admin­istra­tion-related re­ac­tions.

Local Reactions

In this pooled safety pop­u­la­tion, in­jec­tion-site re­ac­tions oc­curred in 8% of patients, in­clud­ing Grade 2 re­ac­tions in 0.6%. The most fre­quent (>1%) in­jec­tion-site re­ac­tion was in­jec­tion site erythema. These local re­ac­tions oc­curred a median of 7 min­utes (range: 0 min­utes to 4.7 days) after start­ing admin­istra­tion of DAR­ZA­LEX FASPRO™. Monitor for local re­ac­tions and con­sider symp­tomatic man­age­ment.

Neutropenia

Daratumumab 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. Consider withholding DAR­ZA­LEX FASPRO™ until re­cov­ery of neu­tro­phils. In lower body weight patients re­ceiv­ing DAR­ZA­LEX FASPRO™, higher rates of Grade 3-4 neu­tro­penia were ob­served.

Thrombocytopenia

Daratumumab may in­crease throm­bo­cyto­penia induced by back­ground ther­apy. Monitor com­plete blood cell counts periodically during treat­ment ac­cord­ing to manu­fac­turer's pre­scrib­ing in­for­ma­tion for back­ground ther­a­pies. Consider withholding DAR­ZA­LEX FASPRO™ until re­cov­ery of plate­lets.

Embryo-Fetal Toxicity

Based on the mech­a­nism of action, DAR­ZA­LEX FASPRO™ can cause fetal harm when admin­istered to a pregnant woman. DAR­ZA­LEX FASPRO™ may cause depletion of fetal im­mune cells and de­creased bone density. Advise pregnant women of the po­ten­tial risk to a fetus. Advise females with re­pro­duc­tive po­ten­tial to use ef­fec­tive con­tra­cep­tion during treat­ment with DAR­ZA­LEX FASPRO™ and for 3 months after the last dose.

The com­bi­na­tion of DAR­ZA­LEX FASPRO™ with lena­lido­mide is con­tra­in­di­cated in pregnant women, because lena­lido­mide may cause birth defects and death of the unborn child. Refer to the lena­lido­mide pre­scrib­ing in­for­ma­tion on use during pregnancy.

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 admin­istra­tion. 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 FASPRO™. Type and screen patients prior to start­ing DAR­ZA­LEX FASPRO™.

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 DAR­ZA­LEX FASPRO™-treated patients with IgG kappa myeloma pro­tein.

ADVERSE REACTIONS

The most common ad­verse re­ac­tion (≥20%) with DAR­ZA­LEX FASPRO™ mono­therapy is: upper res­pira­tory tract in­fec­tion. The most common ad­verse re­ac­tions with com­bi­na­tion ther­apy (≥20% for any com­bi­na­tion) in­clude fatigue, nausea, diarrhea, dyspnea, insomnia, pyrexia, cough, muscle spasms, back pain, vomiting, upper res­pira­tory tract in­fec­tion, periph­eral sensory neu­rop­athy, con­sti­pa­tion, and pneu­monia.

The most common he­ma­tol­ogy laboratory ab­nor­mal­i­ties (≥40%) with DAR­ZA­LEX FASPRO™ are de­creased leukocytes, de­creased lym­pho­cytes, de­creased neu­tro­phils, de­creased plate­lets, and de­creased hemoglobin.

Please see full Prescribing In­for­ma­tion at www.DARZALEX.com.

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, www.twitter.com/JanssenUS, and www.twitter.com/janssenEMEA. Janssen Bio­tech, Inc., Janssen Re­search & De­vel­op­ment, LLC and Janssen-Cilag 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 DAR­ZA­LEX FASPRO™. 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 Bio­tech, Inc., Janssen-Cilag and 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 29, 2019, 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. Comparison of Poma­lido­mide and Dexa­meth­a­sone With or Without Dara­tu­mu­mab in Subjects With Re­lapsed or Re­frac­tory Multiple Myeloma Previously Treated With Lena­lido­mide and a Pro­te­a­some Inhibitor: Daratumumab / Poma­lido­mide / Dexa­meth­a­sone vs Poma­­lido­­mide / Dexa­meth­a­sone (EMN14). Available at: https://clinicaltrials.gov/ct2/show/record/NCT03180736 Last accessed: Octo­ber 2020.
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Source: Janssen.