Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj)/DARZALEX® (daratumumab) Subcutaneous (SC) Formulation in Combination With Pomalidomide and Dexamethasone for Patients With Relapsed or Re

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, NJ, USA I November 12, 2020 I 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.

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/JanssenGlobalwww.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.

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 InhibitorDaratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). Available at: https://clinicaltrials.gov/ct2/show/record/NCT03180736 Last accessed: October 2020.
2 Chari, Ajai et al. "Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma." Blood vol. 130,8 (2017): 974-981. doi:10.1182/blood-2017-05-785246
3 "DARZALEX® (Daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma." Janssen, 16 Nov. 2015, www.jnj.com/media-center/press-releases/darzalex-daratumumab-approved-by-us-fda-first-human-anti-cd38-monoclonal-antibody-available-for-the-treatment-of-multiple-myeloma
4 "Janssen's Single-Agent DARZALEX® (Daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM)." Jannsen.com/Emea, Janssen, 23 May 2016, www.janssen.com/emea/sites/www_janssen_com_emea/files/janssen_darzalex_ec_approval_press_release_2016_05_23_final.pdf.
5 Center for Drug Evaluation and Research. "FDA Approves Daratumumab and Hyaluronidase-Fihj for Multiple Myeloma." U.S. Food and Drug Administration, FDA, 1 May 2020, www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-daratumumab-and-hyaluronidase-fihj-multiple-myeloma.
6 "European Commission Grants Marketing Authorisation for DARZALEX®▼(Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications." Business Wire, 4 June 2020, www.businesswire.com/news/home/20200604005487/en/European-Commission-Grants-Marketing-Authorisation-for-DARZALEX%C2%AE%E2%96%BC-daratumumab-Subcutaneous-Formulation-for-all-Currently-Approved-Daratumumab-Intravenous-Formulation-Indications.
7 Janssen World wide patients as of October 2020
8 European Medicines Agency. DARZALEX summary of product characteristics. Available at: https://www.ema.europa.eu/documents/product-information/darzalex-epar-productinformation_en.pdf Last accessed May 2020
9 2020 Fedele G et al. CD38 Ligation in Peripheral Blood Mononuclear Cells of Myeloma Patients Induces Release of Protumorigenic IL-6 and Impaired Secretion of IFNγ Cytokines and Proliferation. Mediators Inflamm. 2013;564687.
10 Janssen Research & Development, LLC. A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009?term=mmy3003&rank=1 Identifier: NCT02136134. Last accessed: October 2020.
11 Janssen Research & Development, LLC. Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134?term=mmy3004&rank=1 Identifier: NCT02076009. Last accessed: October 2020.
12 Janssen Research & Development, LLC. A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (Cassiopeia). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383?term=mmy3006 Identifier: NCT02541383. Last accessed: October 2020.
13 Janssen Research & Development, LLC. A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479?term=mmy3007&rank=1 Identifier: NCT02195479. Last accessed: October 2020.
14 Janssen Research & Development, LLC. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172?term=mmy3008&rank=1 Identifier: NCT02252172. Last accessed: October 2020.
15 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. Last accessed: October 2020.
16 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. Last accessed: October 2020.
17 Amgen. Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03158688?term=NCT03158688&rank=1 Identifier: NCT03158688. Last accessed: October 2020.
18 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/NCT03158688?term=NCT03158688&rank=1 Identifier: NCT02316106. Last accessed: October 2020.
19 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. Last accessed: October 2020.

SOURCE: Janssen

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