Janssen is applying to the European Commission for approval of a new indication for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma
Saturday, June 03, 2023
The application to the European Medicines Agency is based on data from the phase III CARTITUDE-4 study evaluating the safety profile and efficacy of cilta-cel in the treatment of patients who have received up to three prior lines of therapy became
CARTITUDE-4 is the first randomized phase III study evaluating the efficacy of cell therapy after the first relapse in multiple myeloma
BEERSE, BELGIUM, June 02, 2023 (GLOBE NEWSWIRE) -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it has submitted a Type II Variation Application to the European Medicines Agency (EMA) seeking approval for a new indication for CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma.
"The European Commission's earlier approval confirmed cilta-cel's potential to positively impact outcomes for people with relapsed and refractory multiple myeloma," said Edmond Chan, MBChB MD (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today's submission to the EMA is an important step in enabling patients to benefit from this CAR-T therapy earlier in their treatment. If approved, this will be the first and only CAR-T therapy available for second-line treatment of patients with relapsed and refractory multiple myeloma.”
The filing is supported by data from the CARTITUDE-4 study ( NCT04181827 ), the first randomized phase III study evaluating the efficacy and safety profile of cilta-cel compared to pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy. 1
Results from the CARTITUDE-4 study will be presented in a special session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois on Monday, June 5, 2023; presented at 16:45 CEST.
"This filing is a testament to our relentless commitment to advancing science, improving outcomes, challenging the meaning of the diagnosis of multiple myeloma to patients, and ultimately working towards our goal of one day curing this complex disease," said Sen Zhuang, MD, Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. "We look forward to working with the EMA to advance this potential new indication for cilta-cel for the treatment of multiple myeloma as soon as possible."
Über Ciltacabtagene Autoleucel (cilta-cel)
Cilta-cel received conditional marketing authorization from the European Commission in May 2022 for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody , and in whom the disease has progressed on the last therapy. 3,4 In February 2022, the FDA approved cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody . 5
Cilta-cel is a B-cell maturation antigen (BCMA)-targeted, genetically engineered autologous T-cell immunotherapy in which a patient's own T-cells are reprogrammed with a transgene encoding a chimeric antigen receptor (CAR) that identifies cells and eliminated that express BCMA. 6 BCMA is mainly expressed on the surface of B-lineage multiple myeloma malignant cells and late-stage B cells and plasma cells. 7,8 The CAR protein of cilta-cel contains two single-domain anti-BCMA antibodies with high avidity for human BCMA. 6 The CAR-modified T cells express fusion proteins of antigen receptors against tumor-associated surface antigens and T-cell activation domains, redirect the effector T-cells after binding to BCMA-expressing cells and enhance tumor-specific immune surveillance. 9
In December 2017, Janssen Biotech, Inc. (Janssen) entered into a worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize cilta-cel. 10
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells found in the bone marrow. 11 In multiple myeloma, these malignant plasma cells change and grow out of control. 8 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020 and more than 32,400 patients died. 12 While some patients with multiple myeloma have no symptoms at first, others may experience the usual signs and symptoms of the disease, such as broken bones or pain, low red blood cell counts, fatigue, high calcium levels, or kidney failure. 13
About Johnson & Johnson's Janssen Pharmaceutical Companies
At Janssen, we are building a future where disease is a thing of the past. We are the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients around the world by fighting disease with science, improving access to medicines with ingenuity and healing hopelessness with heart. We focus on the areas of medicine where we can make the greatest difference: cardiovascular disease, metabolic and retinal diseases, immunology, infectious diseases and vaccines, neuroscience, oncology and pulmonary hypertension.
Visit www.janssen.com/emea for more information . Follow us at www.twitter.com/janssenEMEA to stay up to date.
Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of Johnson & Johnson's Janssen Pharmaceutical Companies.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 relating to ciltacabtagene autoleucel (cilta-cel). Readers are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. Should underlying assumptions prove inaccurate, or should known or unknown risks or uncertainties materialize, actual results could differ materially from the expectations and forecasts of Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Research & Development, LLC and Janssen Biotech, Inc., as well as other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, among others: challenges and uncertainties associated with product research and development, including the uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents from competitors; patent challenges; product efficacy or safety concerns that result in product recalls or regulatory action; changes in the behavior and spending patterns of purchasers of healthcare products and services; changes in applicable laws and regulations, including global healthcare reforms; and trends in health care cost containment. A further listing and description 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 1, 2023, including the sections headed "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors,” and in subsequent Johnson & Johnson quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these submissions are online at changes in applicable laws and regulations, including global healthcare reforms; and trends in health care cost containment. A further listing and description 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 1, 2023, including the sections headed "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors,” and in subsequent Johnson & Johnson quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these submissions are online at changes in applicable laws and regulations, including global healthcare reforms; and trends in health care cost containment. A further listing and description 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 1, 2023, including the sections headed "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors,” and in subsequent Johnson & Johnson quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these submissions are online at A further listing and description 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 1, 2023, including the sections headed "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors,” and in subsequent Johnson & Johnson quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these submissions are online at A further listing and description 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 1, 2023, including the sections headed "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors,” and in subsequent Johnson & Johnson quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these submissions are online at and in Johnson & Johnson's subsequent quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these submissions are online at and in Johnson & Johnson's subsequent quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these submissions are online at www.sec.gov or www.jnj.com or upon request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes any obligation to update any forward-looking statement, whether as a result of new information or future events or developments.
Credentials
[1] ClinicalTrials.gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). Available at: https://clinicaltrials.gov/ct2/show/NCT04181827?term=JNJ-68284528&phase=2&draw=2&rank=1 . Last accessed May 2023.
[2] ClinicalTrials.gov. Search results for "CAR-T", "Multiple Myeloma", "Phase 3 studies". Available at: https://clinicaltrials.gov/ct2/results?term=CAR-T&cond=Multiple+Myeloma&age_v=&gndr=&type=&rslt=&phase=2&Search=Apply . Last accessed May 2023.
[3] Janssen.com. European Commission Grants Conditional Approval of CARVYKTI ® (Ciltacabtagene Autoleucel), Janssen's First Cell Therapy, for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma. Available at: https://www.janssen.com/european-commission-grants-conditional-approval-carvykti-ciltacabtagene-autoleucel-janssens-first . Accessed May 2023.
[4] European Medicines Agency. Summary of Product Characteristics CARVYKTI (Ciltacabtagene Autoleucel). Available at: https://www.ema.europa.eu/en/documents/product-information/carvykti-epar-product-information_en.pdf . Last accessed May 2023.
[5] JnJ.com U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. Verfügbar unter: https://www.jnj.com/u-s-fda-approves-carvykti-ciltacabtagene-autoleucel-janssens-first-cell-therapy-a-bcma-directed-car-t-immunotherapy-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma. Letzter Zugriff: Mai 2023.
[6] Martin T, et al. Ciltacabtagene Autoleucel, an Anti–B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 2-Year Follow-Up. J Clin Oncol. 2022;41:1265-1274.
[7] Frerichs KA, et al. Preclinical Activity of JNJ-7957, a Novel BCMA×CD3 Bispecific Antibody for the Treatment of Multiple Myeloma, Is Potentiated by Daratumumab. Clin Cancer Res. 2020;26(9):2203-2215.
[8] Cho SF, et al. Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Front Immunol. 2018;10(9):1821.
[9] Tai YT, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-1199.
[10] JnJ.com Janssen Enters Worldwide Collaboration and License Agreement with Chinese Company Legend Biotech to Develop Investigational CAR-T Anti-Cancer Therapy. Verfügbar unter: https://www.jnj.com/media-center/press-releases/janssen-enters-worldwide-collaboration-and-license-agreement-with-chinese-company-legend-biotech-to-develop-investigational-car- t-anti-cancer-therapy . Accessed May 2023.
[11] American Cancer Society. "What Is Multiple Myeloma?" Available at: https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html . Accessed May 2023.
[12] GLOBOCAN 2020. Cancer Today Population Factsheets: Europe Region. Available at: https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf . Accessed May 2023.
[13] American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available under: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf . Last accessed May 2023.
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