Business Wire

European Commission Extends Approval for Janssen’s DARZALEX®▼(daratumumab) to Include Multiple Myeloma Patients Who Have Received at Least One Prior Therapy


Janssen-Cilag International NV (“Janssen”) today announced that the European Commission (EC) has granted approval to DARZALEX®▼ (daratumumab) for use in combination with lenalidomide and dexamethasone, or bortezomib (VELCADE®) and dexamethasone, for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.

The EC’s decision was based on data from the Phase 3 POLLUX (MMY3003) study, presented in the plenary session at ASCO 2016 and published in the New England Journal of Medicine, in August 20161; and Phase 3 CASTOR (MMY3004) study, presented in the Presidential session at EHA 2016 and also published in the New England Journal of Medicine in October 2016.2 The addition of daratumumab significantly reduced the risk of disease progression or death, by 63% in POLLUX and 61% in CASTOR, when combined with standard of care regimens (p<0.001 in both studies).1,2

The safety profile of daratumumab in combination with standard of care regimens was consistent with daratumumab monotherapy studies and with that for the standard of care regimens. In combination with lenalidomide and dexamethasone (POLLUX), the most common adverse events of grade 3 or 4 during treatment were neutropenia (51.9%), thrombocytopenia (12.7%), and anaemia (12.4%).1 Daratumumab-associated infusion-related reactions occurred in 47.7% of the patients and were mostly of grade 1 or 2.1 In combination with bortezomib and dexamethasone (CASTOR) three of the most common grade 3 or 4 adverse events reported were thrombocytopenia (45.3%), anaemia (14.4%), and neutropenia (12.8%).2 Infusion-related reactions that were associated with daratumumab treatment were reported in 45.3% of the patients; these reactions were mostly grade 1 or 2 (grade 3 in 8.6% of patients), and in 98.2% of these patients, they occurred during the first infusion.2

“Data from both the CASTOR and POLLUX studies demonstrated improved progression-free survival and a reduction in disease progression or death compared to standard of care,” said Torben Plesner, M.D., Vejle Hospital, Vejle, Denmark, a daratumumab clinical trial investigator. “Together, these results show daratumumab in combination with either a proteasome inhibitor or an immunomodulatory agent has the potential to provide clinical benefit to patients after one or more lines of therapy.”

“This approval is an important step for people living with multiple myeloma across our region and offers some patients a new treatment option. We are encouraged by the data we have seen for daratumumab to date and will continue to investigate its potential,” said Dr Catherine Taylor, Haematology Therapeutic Area Lead, Janssen Europe, Middle East and Africa (EMEA).

The initial Marketing Authorisation was granted in May 2016 for daratumumab as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.3 This Authorisation was marked as conditional based on Janssen providing additional data from the MMY3003 (POLLUX) and MMY3004 (CASTOR) studies.4 With the provision of these results, the EC has considered the Specific Obligations associated with the conditional Marketing Authorisation to have been fulfilled, allowing the switch from conditional to full approval.5


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.6 MM is the second most common form of blood cancer, with around 39,000 new cases worldwide in 2012.7 MM most commonly affects people over the age of 65 and is more common in men than in women.8 The most recent five-year survival data for 2000-2007 show that across Europe, up to half of newly diagnosed patients do not reach five-year survival. 9 Almost 29% of patients with MM will die within one year of diagnosis.10 Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure. 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.8 Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.11

About Daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.12-14 Daratumumab induces rapid tumour cell death through apoptosis (programmed cell death)4,15 and multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).4,16,17 Daratumumab has also demonstrated immunomodulatory effects that contribute to tumour cell death via a decrease in immune suppressive cells including T-regs, B-regs and myeloid-derived suppressor cells.4,18 Daratumumab is being evaluated in a comprehensive clinical development programme that includes five Phase 3 studies across a range of treatment settings in multiple myeloma. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases in which CD38 is expressed. For more information, please see

For further information on daratumumab, please see the Summary of Product Characteristics at

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab.

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at Follow us at

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding potential benefits and treatment options related to DARZALEX ® (daratumumab). 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-Cilag International NV, 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 or financial distress 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 1, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.



1. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide and dexamethasone for multiple myeloma. N Engl J Med. 2016;375:1319–31.

2. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib and dexamethasone for relapsed and refractory multiple myeloma. N Engl J Med. 2016;375:754–66.

3. Janssen. Janssen’s Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM). Available at: Last accessed March 2017.

4. European Medicines Agency. DARZALEX summary of product characteristics, May 2016. Available at: Last accessed March 2017.

5. European Medicines Agency. DARZALEX Summary of Opinion 23 February 2017. Available at: Last accessed March 2017.

6. American Society of Clinical Oncology. Multiple myeloma: overview. Available at: Last accessed March 2017.

7. GLOBOCAN 2012. Multiple myeloma. Available at: Last accessed March 2017.

8. American Cancer Society. Multiple myeloma: detailed guide. Available at: Last accessed March 2017.

9. 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.

10. Costa LJ, Gonsalves WI, Kumar SK. Early mortality in multiple myeloma. Leukemia. 2015;29:1616-8.

11. 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.

12. 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.

13. Lin P, Owens R, Tricot G, et al. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol. 2004;121:482-8.

14. Santoconito AM, Consoli U, Bagnato S et al. Flow cytometric detection of aneuploid CD38++ plasmacells and CD19+ B-lymphocytes in bone marrow, peripheral blood and PBSC harvest in multiple myeloma patients. Leuk Res. 2004;28:469-77.

15. Overdijk MB, Jansen JH, Nederend M, et al. The therapeutic CD38 monoclonal antibody daratumumab induces programmed cell death via Fcy receptor-mediated cross-linking. J Immunol. 2016;197:807-13.

16. de Weers M, Tai YT, van der Veer MS, et al. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol. 2011;186:1840-8.

17. Overdijk MB, Verploegen S, Bögels M, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015;7:311-21.

18. Krejcik J, Casneuf T, Nijhof IS, et al. Daratumumab depletes CD38+ immune-regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood. 2016;128:384-94.


March 2017

Contact information

Media Enquiries:
Natalie Buhl
Mobile: +353 (0)85-744-6696
Investor Relations:
Lesley Fishman
Phone: +1 732-524-3922
Joseph J. Wolk
Phone: +1 732-524-1142

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

FAA Approves AerTrakTM to Comply with Automatic Dependent Surveillance-Broadcast (ADS-B) Operations Mandate19.3.2018 18:19Pressemelding

The Federal Aviation Administration (FAA) has issued a Supplemental Type Certificate (STC) for installation of AerSale®’s AerTrak™ system on Boeing 737 NG series aircraft (ST04009NY), to comply with the Automatic Dependent Surveillance-Broadcast (ADS-B) Operations rule, a critical part of the agency’s Next Generation Air Transportation System (NextGen). Beginning January 1, 2020, the FAA has mandated that aircraft operating in airspace defined by 14 CFR § 91.225 must be equipped with an ADS-B Out system that meets the minimum performance requirements of 14 CFR § 91.227. ADS-B provides enhanced navigational accuracy using precise tracking via global positioning satellite (GPS) signals. Reducing risk and improving safety, the technology increases navigational coverage, especially in remote areas beyond radar range. Additionally, ADS-B enables more direct flight plans, thereby saving time, costs, and reducing emissions. “AerTrak is a cost-effective ADS-B Out solution for operators of Boei

Ghostbusters World with Google Maps API Featured During Google Keynote at GDC 201819.3.2018 18:14Pressemelding

The recently announced Ghostbusters World, developed in collaboration between Sony Pictures Entertainment Consumer Products, Ghost Corps and publisher FourThirtyThree Inc. (4:33), was featured today on stage during the Google Keynote at the Game Developers Conference 2018. The new gameplay video will also be on display at the Google booth on the expo floor March 21-23. Created with Maps API technology, Ghostbusters World features state-of-the-art augmented reality in the map-based game where players can suit up to patrol their neighborhoods and bust their favorite Ghostbusters ghosts! Drop by the Google booth or click here (LINK) to check out the new gameplay video. Battle and capture hundreds of new and familiar ghosts in Ghostbusters World, launching everywhere on iOS and Android devices later this year. If you ain’t afraid of no ghosts and want to keep track of news and updates, follow us on Twitter (LINK), Facebook (LINK), and YouTube (LINK). More information and assets can be foun

Bajaj Electricals Showcases ‘Smart Indoors and Connected Outdoors’ at Light + Building 201819.3.2018 16:00Pressemelding

Bajaj Electricals Limited, India’s leading player in consumer durables, fans, lighting and engineering projects, participates in world’s leading trade fair Light + Building 2018 at Frankfurt, Germany from March 18th-23rd, 2018. Bajaj Electricals is featuring its smart solutions at Stall D10 in outdoor arena-Agora. This press release features multimedia. View the full release here: Mr. Anant Bajaj, Joint Managing Director, Bajaj Electricals Ltd. (Photo: Business Wire) Based on the key theme of ‘Smart Indoors and Connected Outdoors’, the stall demonstrates the connection between indoors and outdoors through cloud computing. With almost eight decades of experience and expertise in lighting solutions and luminaires, Bajaj Electricals has a host of products exhibited at the trade fair ranging from smart indoor lights for home, commercial and industrial spaces to smart outdoor lights, sensor-based light, smart poles and various integra

Louis Chevrolet Watch Company launches the Chrono-Tour Bitcoin Special Edition19.3.2018 15:00Pressemelding

Code name: Chrono-Tour Bitcoin Special Edition – Launch: 20/03/2018 – 14.00 GMT This press release features multimedia. View the full release here: (Photo: Louis Chevrolet Swiss Watches) Event! Louis Chevrolet Swiss Watches launches a Swiss Made automatic chronograph dedicated only to Bitcoin owners. An exclusive and limited-edition series to symbolise and affirm the unique sales channel chosen by the brand: its e-commerce store. Each Louis Chevrolet Chrono Tour Bitcoin Special Edition will be Unique Chrono-Tour Bitcoin Special Edition, a well-thought-out stylish design, elegantly bringing the Bitcoin to the forefront. In addition to a specific dial, a Bitcoin logo textured around a printed circuit board will be inserted into the back glass. This gives a technological holographic effect while highlighting the mechanics of the watch. The background will be personalised with a laser and will indicate the purchase price in Bitcoins

New Global Survey Points to Key Issues, Needs and Gaps in Fight to End Smoking19.3.2018 14:00Pressemelding

The Foundation for a Smoke-Free World released findings today from a global survey to better understand smokers, their experiences, and challenges they face when they try to quit smoking. The survey also highlights their awareness regarding the harm caused by smoking and how their perceptions of cigarettes, alternative products, and nicotine influence their motivation to move away from smoking. The data will shape the development of research to determine the best solutions to accelerate the end of smoking across diverse cultures and economic conditions. This press release features multimedia. View the full release here: Figure 1: Which of the following situations, if any, apply to you? (% - Top Three Answers per Country) (Graphic: Business Wire) The 2018 State of Smoking Survey included 17,421 current smokers, ex-smokers, and non-smokers from 13 countries: Brazil, France, Greece, India, Israel, Japan, Lebanon, Malawi, New Zealan

New Documentary Raises Global Water Crisis Awareness As 844 Million People Still Lack Access to Clean Drinking Water19.3.2018 13:12Pressemelding

Procter & Gamble’s (P&G) non-profit Children’s Safe Drinking Water (CSDW) Program and National Geographic are raising awareness about the global water crisis with the release of a new documentary and national survey in conjunction with World Water Day. The documentary, titled “The Power of Clean Water,” follows the lives of three women and their families, providing a first-hand perspective on the daily challenges of accessing clean drinking water. As the film progresses, viewers witness how P&G’s Purifier of Water packets, distributed by partners ChildFund in Indonesia, CARE International in Kenya and World Vision in Mexico, have helped transform these communities. This press release features multimedia. View the full release here: P&G conducted a survey* to understand Americans' level of awareness and concern with the global water crisis and its effects. (Graphic: Business Wire) Global awareness of the water crisis is growing,