DARZALEX? SC Becomes the First and Only Health Canada-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis, A Rare Disease
ANDROMEDA (AMY3001) is an ongoing Phase 3, randomized, open-label study investigating the safety and efficacy of DARZALEX??SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd), compared to VCd alone, for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.14?The study includes 388 patients with newly diagnosed AL amyloidosis with measurable hematologic disease and one or more organs affected.15?The primary endpoint is overall complete hematologic response rate by intent-to-treat (ITT).16?Patients received DARZALEX??SC 1,800?mg administered subcutaneously once weekly from weeks?1 to 8, once every 2?weeks from weeks?9 to 24 and once every 4?weeks starting with week?25 until disease progression or unacceptable toxicity or a maximum of 2?years.17?Among patients who received D-VCd, 74 per cent were exposed for 6?months or longer and 32 per cent were exposed for greater than one year.18 The most common treatment-emergent adverse events (=20 per cent) in the D-VCd arm were peripheral edema, fatigue, diarrhea, constipation, nausea, upper respiratory tract infection, peripheral sensory neuropathy, dyspnea, cough, insomnia, and anemia.?19?Serious treatment-emergent adverse events occurred in 43 per cent of patients in the D-VCd arm. Serious treatment-emergent adverse events that occurred in at least 5 per cent of patients in the D?VCd arm were pneumonia (7 per cent) and cardiac failure (7 per cent).?20?Fatal adverse reactions occurred in 11 per cent of patients in the D-VCd arm.?21?Fatal adverse reactions that occurred in more than one patient included cardiac arrest, sudden death, and cardiac failure (3 per cent respectively), and sepsis (1 per cent).22 About DARZALEX??SC DARZALEX??is the first CD38-directed monoclonal antibody (mAb) approved to treat multiple myeloma.23?In 2020, DARZALEX??SC became the only subcutaneously administered CD38-directed antibody approved to treat patients with multiple myeloma.24?And now, DARZALEX??SC in combination with bortezomib, cyclophosphamide and dexamethasone?is the first and only Health Canada approved treatment for patients with AL amyloidosis.?25?The safety and efficacy of DARZALEX??SC have not been established in AL amyloidosis patients with advanced cardiac disease (Mayo Stage IIIB or NYHA Class IIIB or IV).26 Daratumumab binds to CD38,?a surface protein highly expressed across clonal plasma cells that cause serious conditions such as multiple myeloma and AL amyloidosis.27?Daratumumab induces tumor cell death through cell lysis via multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).28?Daratumumab?has also demonstrated immunomodulatory effects such as increasing CD4+ and CD8+ T-cells counts, which may contribute to clinical response.29 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?. Janssen Inc. commercializes DARZALEX??and DARZALEX??SC?in?Canada. For full Prescribing Information and more information about DARZALEX??SC,?please visit?www.janssen.com/canada.?? 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/canada. Follow us at @JanssenCanada. Janssen Inc. is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. *All trademark rights used under license.
**Dr. Zepeda was not compensated for any media work. He has been compensated as a consultant. 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??SC. 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 Inc., 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?January 3, 2021, 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:
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1?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
2?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
3?Leukemia & Lymphoma Society of Canada. "Amyloidosis Facts." Available at:?https://www.llscanada.org/sites/default/files/file_assets/Amyloidosis%20FINAL.pdf. Accessed March 2021 |
4?Leukemia & Lymphoma Society of Canada. "Amyloidosis Facts." Available at:?https://www.llscanada.org/sites/default/files/file_assets/Amyloidosis%20FINAL.pdf. Accessed March 2021 |
5?Kastritis E, et al. Subcutaneous Daratumumab + Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis: Primary Results from the Phase 3 ANDROMEDA Study. Available at:?https://library.ehaweb.org/eha/2020/eha25th/303396/efstathios.kastritis.subcutaneous.daratumumab.2B.cycl%20ophosphamide.bortezomib.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Amedia%3D3%2Ace_i. Accessed March 2021 |
6?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
7?Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928 |
8?Mayo Clinic. Amyloidosis overview: symptoms and causes. Available at:?https://www.mayoclinic.org/diseases-conditions/amyloidosis/symptoms-causes/syc-20353178. Accessed March 2021 |
9?Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928 |
10?Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928 |
11?McCausland KL, et al. Patient. 2018;11(2):207-216 |
12?Mayo Clinic. Amyloidosis diagnosis and treatment?https://mayocl.in/3jK50G4. Accessed March 2021 |
13?Merlini G, et al.?Light chain amyloidosis: the heart of the problemHaematologica. 2013;98(10):1492-1495 |
14?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
15?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
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17?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
18?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
19?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
20?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
21?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
22?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
23?Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at:?https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565 |
24?Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at:?https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565 |
25?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
26?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
27?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
28?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |
29?[DARZALEX? SC Product Monograph, Janssen Inc., April 12, 2021] |