CHMP Grants Positive Opinion for Expanded Use of Janssen’s Darzalex®▼(daratumumab) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Darzalex® (daratumumab) to include the use of daratumumab in combination with lenalidomide and dexamethasone (DRd) for patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT).
“As multiple myeloma can become more complex with each relapse, it is important that patients receive the latest treatment options with the goal of extending their first remission period,” said Professor Thierry Facon, M.D., Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France, and principal investigator of the MAIA study. “For newly diagnosed patients who are transplant ineligible, this regimen could be an important frontline therapy option and reinforces the consistent clinical profile of daratumumab.”
This Positive Opinion is based on results from the Phase 3 MAIA (MMY3008) study, published in The New England Journal of Medicine, 1 and presented at the 2018 American Society of Hematology (ASH) Annual Meeting.
Additional information about the MAIA study can be found at www.ClinicalTrials.gov (NCT02252172).
“This recommendation marks an important step towards realising our ambition to improve outcomes for patients with multiple myeloma, right from diagnosis, especially for the majority of patients who are not eligible for transplant,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC.
“Daratumumab has been used to treat more than 100,000 patients worldwide and we look forward to working with regulatory authorities to bring this important therapy to even more patients with multiple myeloma,” adds Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag France.
This Opinion will now be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.
Professor Thierry Facon was the principal investigator in the MAIA study. He was not compensated for any media work.
About the MAIA (NCT02252172) Trial2
The randomised, open-label, multicentre Phase 3 study included 737 NDMM patients ineligible for high-dose chemotherapy and ASCT aged 45-90 years old (median age of 73 years). Patients were randomised to receive either daratumumab-Rd or Rd alone in 28-day Cycles. In the daratumumab-Rd treatment arm, patients received daratumumab 16 (mg/kg) IV weekly for Cycles 1 – 2, every two weeks for Cycles 3 – 6 and every 4 weeks for Cycle 7 and thereafter. The primary endpoint was Progression-Free Survival (PFS), defined as the time from date of randomisation to either progressive disease (PD), or death, whichever occurred first. Patients in the daratumumab-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.
Daratumumab is a first-in-class3 biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.4 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.5 A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.5 Since launch, it is estimated that 100,000 patients have been treated with daratumumab worldwide.6 Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.7,8,9,10,11,12,13,14 Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.15,16 For more information, please see www.clinicaltrials.gov.
The most frequent adverse reactions seen with daratumumab include infusion reactions, fatigue, nausea, diarrhoea, muscle spasms, pyrexia, cough, neutropenia, thrombocytopenia, anaemia, peripheral sensory neuropathy and upper respiratory tract infection.5
For further information on daratumumab, please see the Summary of Product Characteristics at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex.
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.17
About Multiple Myeloma
Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.18 In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died.19 Almost 60 percent of patients with MM do not survive more than five years after diagnosis.20
Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.21 Refractory MM is when a patient’s disease progresses within 60 days of their last therapy.22,23 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.24 While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.25 Patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.26
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/emea. Follow us at www.twitter.com/janssenEMEA for our latest news. Janssen-Cilag, Janssen Biotech, Inc. and Janssen Research & Development, LLC 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 the benefits of daratumumab for the treatment of patients with multiple myeloma. 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 materialise, actual results could vary materially from the expectations of the 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 behaviour 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. Neither the Janssen Pharmaceutical Companies of Johnson & Johnson nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H. e. 2019 May 30;380(22):2104-15.
2 ClinicalTrials.gov. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. NCT02252172. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172 Last accessed October 2019.
3 Sanchez L, Wang Y, Siegel DS, Wang ML. Daratumumab: a first-in-class CD38 monoclonal antibody for the treatment of multiple myeloma. J Hematol Oncol. 2016;9:51.
4 Fedele G, di Girolamo M, Recine U, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNgamma cytokines and proliferation. Mediat Inflamm. 2013;2013:564687.
5 European Medicines Agency. DARZALEX summary of product characteristics, August 2019. Available at: https://www.ema.europa.eu/documents/product-information/darzalex-epar-product-information_en.pdf. Last accessed October 2019.
6 Janssen Data on file. RF-82203. New patient starts: launch to date. October 2019.
7 ClinicalTrials.gov. A study to evaluate daratumumab in transplant eligible participants with previously untreated multiple myeloma (Cassiopeia). NCT02541383. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383 Last accessed October 2019.
8 ClinicalTrials.gov. A study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma. NCT02076009. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009 Last accessed October 2019.
9 ClinicalTrials.gov. Addition of daratumumab to combination of bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma. NCT02136134. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134 Last accessed October 2019.
10 ClinicalTrials.gov. 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. NCT02195479. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479 Last accessed October 2019.
11 ClinicalTrials.gov. Study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in participants with previously untreated multiple myeloma. NCT02252172. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172 Last accessed October 2019.
12 ClinicalTrials.gov. 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). NCT03217812. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812 Last accessed October 2019.
13 ClinicalTrials.gov. 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). NCT03180736. Available at: https://clinicaltrials.gov/ct2/show/NCT03180736 Last accessed October 2019.
14 ClinicalTrials.gov. Study of carfilzomib, daratumumab and dexamethasone for patients with relapsed and/or refractory multiple myeloma (CANDOR). NCT03158688. Available at: https://clinicaltrials.gov/ct2/show/NCT03158688 Last accessed October 2019.
15 ClinicalTrials.gov. A study to evaluate 3 dose schedules of daratumumab in participants with smoldering multiple myeloma. NCT02316106. Available at: https://clinicaltrials.gov/ct2/show/NCT02316106 Last accessed October 2019.
16 ClinicalTrials.gov. An efficacy and safety proof of concept study of daratumumab in relapsed/refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma. NCT02413489. Available at: https://clinicaltrials.gov/ct2/show/NCT02413489 Last accessed October 2019.
17 Johnson & Johnson. Janssen Biotech announces global license and development agreement for investigational anti-cancer agent daratumumab. Press release August 30, 2012. Available at: https://www.jnj.com/media-center/press-releases/janssen-biotech-announces-global-license-and-development-agreement-for-investigational-anti-cancer-agent-daratumumab Last accessed October 2019.
18 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction Last accessed October 2019.
19 GLOBOCAN 2018. Cancer Today Population Factsheets: Europe Region. Available at: https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf Last accessed October 2019.
20 De Angelis R, Minicozzi P, Sant M, et al. Survival variations by country and age for lymphoid and myeloid malignancies in Europe 2000-2007: results of EUROCARE-5 population-based study. Eur J Cancer. 2015;51:2254-68.
21 Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–207.
22 National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245 Last accessed October 2019.
23 Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.
24 National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866 Last accessed October 2019.
25 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf Last accessed October 2019.
26 Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.
Mobile: +31 621 38 5718
Phone: +1 732-524-2955
Phone: +1 732-524-3922
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Meet Global Exhibitors and Hear from World-Renowned Speakers at CHTF201914.11.2019 01:00:00 CET | Press release
The 21st China Hi-Tech Fair (CHTF2019), themed “invigorating the Great Bay Area through opening up and innovation,” opened on November 13-17, 2019 in Shenzhen, China. Visitors will meet leading local and global hi-tech enterprises as well as Nobel laureate speakers. Featuring the technological achievements in the Guangdong-Hong Kong-Macau Greater Bay Area, CHTF2019 created an online VR exhibition hall for key exhibitors, especially enterprises from the Area, to help them reach a larger audience apart from on-site visitors. Chamtent Technology (Booth: 2G69), focusing on smart household products, has developed a series of environment-friendly products such as smart trash cans, as well as the HyperLink Automatic Waste Recycled System to be applied in modern residential communities to make life more effective. ISUKE Technology (Booth: 2D31) focuses on health management for both professional healthcare institutions and individuals. Its innovative health information collection devices (inclu
Juan Carro Arbelo Appointed as Regional Manager for Insurance, Iberia13.11.2019 19:00:00 CET | Press release
Starr Insurance Companies today announced the appointment of Juan Carro Arbelo as Regional Manager for Insurance, Iberia, subject to regulatory approval. Mr. Carro is responsible for the development of Starr’s commercial lines presence across the Iberian Peninsula, effective November 4, 2019. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191113005709/en/ (Photo: Business Wire) “Juan brings more than 22 years of insurance industry experience working on both the brokerage and carrier sides of the business,” stated Maurice R. Greenberg, Chairman and CEO, Starr Insurance Companies. “His extensive background in developing and establishing lines of business will aid in growing new channels for Starr across Iberia.” The new role strengthens Starr’s European operations, which now includes the UK, Benelux countries, Central and Eastern Europe and the Iberian Peninsula. The European region offers a wide breadth of Starr’s insurance p
SNCF Selects Klas Telecom TRX R6 for French National Rail Network13.11.2019 17:00:00 CET | Press release
Klas Telecom today announced that, together with their French partner Seolane Innovation, they have entered into an agreement with France’s national rail operator, SNCF to supply the TRX R6 Connected Transportation Platform for implementation on board SNCF’s trains. This agreement comes as the result of a highly competitive public tender in which SNCF sought to acquire an onboard connectivity solution to provide improved operational and passenger-centric services. Julien Baratier, the Project Manager for SNCF commented, "Through this tender process, we sought to develop our onboard technical solution to fulfil our customer requirements in terms of train connectivity and onboard services. Although new partners for us, Klas Telecom and Seolane have demonstrated their technical commitment by offering a modular, flexible and performing solution. We are very excited to now be working together on a first rollout on regional trains to support a CCTV service." Wilfrid Rouger, CEO of Seolane In
U.S. Ambassador Johnson and UK’s Sir Nicholas Soames to join Bermuda Premier at Executive Forum in London13.11.2019 16:17:00 CET | Press release
The United States Ambassador to the United Kingdom (UK), Robert Wood Johnson, and the UK’s Rt. Hon. Sir Nicholas Soames, former defence minister and former Conservative Member of Parliament for Mid Sussex, will join Bermuda’s Premier, the Hon. E. David Burt, JP, MP, at an Executive Forum in London this month to highlight the historic and successful economic relationship that exists between Bermuda, the U.S. and the UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191113005627/en/ Bermuda Executive Forum London 2019 opening panel. (Photo: Business Wire) The keynote conversation between Ambassador Johnson, Sir Nicholas Soames and the Premier will explore the implications of global trends, address key challenges from Brexit to U.S. tax reform, and shed light on new opportunities to further develop economic ties. The discussion will be moderated by Fiona Luck, a Non-Executive Director on the Lloyd’s of London Franchise Board,
Advance Auto Parts, Blue Cross NC, Emory Healthcare, Johnsonville, Parkview Health, and Royal Bank of Scotland Receive Planview Vision Awards13.11.2019 16:01:00 CET | Press release
Over 700 attendees came together at Planview Horizons 2019 to connect, collaborate, and celebrate with their industry peers. This year, Advance Auto Parts, Blue Cross NC, Emory Healthcare, Johnsonville, Parkview Health, and Royal Bank of Scotland were the recipients of Planview Vision Awards for transformational leadership and excellence. “There are many remarkable business transformation journeys that our customers have undertaken leveraging Planview solutions,” said Marc Cannon, Planview chief customer officer. “We were honored at this year’s Planview Horizons to celebrate these six visionary organizations for their commitment to, and success in, achieving their strategic goals.” Advance Auto Parts To address the industry trends around increased use of ridesharing, electric cars, and autonomous vehicles, a few “hidden innovators” at Advance Auto Parts set out to generate and collaborate on new ideas that would disrupt the market and delight their customers. With Planview Spigit™, Adv
CyberOptics Wins Global Technology Award for SQ3000™ Inspection and Metrology System at productronica Germany13.11.2019 14:00:00 CET | Press release
CyberOptics® Corporation (NASDAQ: CYBE), a leading global developer and manufacturer of high-precision 3D sensing technology solutions, announced that it was awarded a 2019 Global Technology Award in the category of Inspection – AOI for its SQ3000™ Multi-Function for AOI, SPI and CMM. The award was presented to the company during a Tuesday, Nov. 12, 2019 ceremony that took place during productronica in Munich, Germany. The 3D SQ3000 all-in-one system can identify critical defects and measure critical parameters, providing a superior process control solution for effective yield management. In addition to AOI and SPI applications, highly accurate coordinate measurements can be attained faster than a traditional Coordinate Measurement Machine (CMM) – in seconds, not hours. The world’s first in-line CMM includes an extensive software suite for metrology grade measurement on all critical points. “We are thrilled to receive our 16th award for Multi-Reflection Suppression (MRS)-enabled system