CHMP Issues Positive Opinion Recommending DARZALEX (Daratumumab) in Combination with Lenalidomide and Dexamethasone in Frontline Multiple Myeloma -…
By daniellenierenberg
Company Announcement
Copenhagen, Denmark; October 18, 2019 Genmab A/S (Nasdaq:GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX (daratumumab) in the European Union. The recommendation is for the use of DARZALEX in combination with lenalidomide and dexamethasone (Rd) as treatment for newly diagnosed adult patients with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The Type II variation application, based on the Phase III MAIA (MMY3008) study, was submitted to the EMA by Janssen Pharmaceutica NV in March 2019. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
We are encouraged that the CHMP are recommending a broadening of the current DARZALEX marketing authorization in the European Union to include DARZALEX in combination with lenalidomide and dexamethasone as a possible treatment for patients newly diagnosed with multiple myeloma. This would give patients another treatment option, in addition to the already approved combination of daratumumab plus bortezomib, melphalan and prednisone in this same setting, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the MAIA (MMY3008) studyThe Phase III study (NCT02252172) is a randomized, open-label, multicenter study that includes 737 newly diagnosed patients with multiple myeloma who are not candidates for high dose chemotherapy and ASCT. Patients were randomized to receive either treatment with daratumumab in combination with lenalidomide (an immunomodulatory drug) and dexamethasone (a corticosteroid) or treatment with lenalidomide and dexamethasone alone. In the daratumumab treatment arm, patients received 16 milligrams per kilogram (mg/kg) weekly for first 8 weeks (Cycles 1 and 2), every other week for 16 weeks (Cycles 3 to 6) and then every 4 weeks (Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide is administered at 25 mg orally on days 1 through 21 of each 28-day cycle, and dexamethasone is administered at 40 mg once a week for both treatment arms. Participants in both treatment arms will continue Rd until disease progression or unacceptable toxicity. The primary endpoint of the study is progression free survival.
About multiple myelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Approximately 16,830 new patients were expected to be diagnosed with multiple myeloma and approximately 10,480 people were expected to die from the disease in the Western Europe in 2018.2 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.3 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.4
About DARZALEX (daratumumab)DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy6. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma and in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.
Story continues
Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).5,6,7,8,9,10
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.
About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, DARZALEX (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with core sites in Utrecht, the Netherlands and Princeton, New Jersey, U.S.
Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com
This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs final prospectus for our U.S. public offering and listing and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX is a trademark of Janssen Pharmaceutica NV.
1 American Cancer Society. "Multiple Myeloma Overview." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed June 2016.2 Globocan 2018. Western Europe Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/926-western-europe-fact-sheets.pdf Accessed March 20183 Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.4 American Cancer Society. "How is Multiple Myeloma Diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 20165 DARZALEX Prescribing information, September 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf Last accessed September 20196 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed October 20197De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.8 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.9 Krejcik MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.10Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974.
Company Announcement no. 50CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
Attachment
Continue reading here:
CHMP Issues Positive Opinion Recommending DARZALEX (Daratumumab) in Combination with Lenalidomide and Dexamethasone in Frontline Multiple Myeloma -...
- 001 Expansion of Stem Cells by Valproic Acid [Last Updated On: June 24th, 2011] [Originally Added On: June 24th, 2011]
- 002 Cord Blood and Bone Marrow Stem Cells for Liver Failure [Last Updated On: June 25th, 2011] [Originally Added On: June 25th, 2011]
- 003 Science behind Enhancing Adult Stem Cells for wellbeing [Last Updated On: June 26th, 2011] [Originally Added On: June 26th, 2011]
- 004 Stem cells Transplatation in Completed Paralyze Dog. [Last Updated On: June 26th, 2011] [Originally Added On: June 26th, 2011]
- 005 STEM CELLS - Bone Marrow Stem Cells (Balzitt).flv [Last Updated On: June 27th, 2011] [Originally Added On: June 27th, 2011]
- 006 Bone Marrow Stem Cells/Gene Therapy [Last Updated On: June 28th, 2011] [Originally Added On: June 28th, 2011]
- 007 Stem cells used for medical treatment [Last Updated On: June 30th, 2011] [Originally Added On: June 30th, 2011]
- 008 STEM CELLS FOR OTHER USES Interview with Sam Smith.wmv [Last Updated On: July 1st, 2011] [Originally Added On: July 1st, 2011]
- 009 Stem Cells Reversing Endothelial Senescence [Last Updated On: July 2nd, 2011] [Originally Added On: July 2nd, 2011]
- 010 Bone Marrow Stem Cells [Last Updated On: July 3rd, 2011] [Originally Added On: July 3rd, 2011]
- 011 Bone marrow transplantation HD, ENG subtitles [Last Updated On: July 5th, 2011] [Originally Added On: July 5th, 2011]
- 012 Adult Stem Cells May Target and Repair Heart Attack Damage [Last Updated On: July 6th, 2011] [Originally Added On: July 6th, 2011]
- 013 Bone Marrow Stem Cell Applications [Last Updated On: July 8th, 2011] [Originally Added On: July 8th, 2011]
- 014 Stem cells in bone marrow are being used to treat EB [Last Updated On: July 13th, 2011] [Originally Added On: July 13th, 2011]
- 015 STEM CELLS FOR MACULAR DEGENERATION Sam Smith's story.wmv [Last Updated On: July 14th, 2011] [Originally Added On: July 14th, 2011]
- 016 MS Cure - Progression [Last Updated On: July 14th, 2011] [Originally Added On: July 14th, 2011]
- 017 Blind Girl get's cure you need to see to believe" [Last Updated On: July 17th, 2011] [Originally Added On: July 17th, 2011]
- 018 From Surgical Repair to Stem Cell Repair: A Surgeon's Journey by Leonard Smith MD, FACS [Last Updated On: July 19th, 2011] [Originally Added On: July 19th, 2011]
- 019 Bone Marrow Stem Cell Donation [Last Updated On: July 19th, 2011] [Originally Added On: July 19th, 2011]
- 020 The potential of stem cells [Last Updated On: July 28th, 2011] [Originally Added On: July 28th, 2011]
- 021 LifeCell in Kalaignar Seithigal,Sun News [Last Updated On: July 31st, 2011] [Originally Added On: July 31st, 2011]
- 022 Spirulina DLA Naturals [Last Updated On: August 6th, 2011] [Originally Added On: August 6th, 2011]
- 023 Bill Lahti; stem cell nutrition stimulates wound repair for diabetic stroke victim [Last Updated On: August 6th, 2011] [Originally Added On: August 6th, 2011]
- 024 Christian Drapeau Talk About - Adult Stem Cells and StemEnhance./StemTech [Last Updated On: August 7th, 2011] [Originally Added On: August 7th, 2011]
- 025 "Bone Marrow Stem Cells" Donald Kohn [Last Updated On: August 14th, 2011] [Originally Added On: August 14th, 2011]
- 026 Cancer Update: Autologus Stem Cell (Bone Marrow) Transplant [Last Updated On: September 4th, 2011] [Originally Added On: September 4th, 2011]
- 027 Bone Marrow / Stem Cell Transplant Recovery Fund [Last Updated On: September 6th, 2011] [Originally Added On: September 6th, 2011]
- 028 Bone Marrow/Stem Cell Transplantation: An Introduction, With Sonali Smith, MD [Last Updated On: September 9th, 2011] [Originally Added On: September 9th, 2011]
- 029 Bone Marrow Stem Cell Transplant Live from Top US Hospital [Last Updated On: September 12th, 2011] [Originally Added On: September 12th, 2011]
- 030 Adult Stem Cell Mobilization from Bone Marrow (Animation) [Last Updated On: September 12th, 2011] [Originally Added On: September 12th, 2011]
- 031 MS Cure - Introduction to stem cell bone marrow transplant in Australia [Last Updated On: September 13th, 2011] [Originally Added On: September 13th, 2011]
- 032 Immune Modulation by Bone Marrow Mesenchymal Stem Cells [Last Updated On: September 14th, 2011] [Originally Added On: September 14th, 2011]
- 033 Bone Marrow/Stem Cell Transplant [Last Updated On: September 15th, 2011] [Originally Added On: September 15th, 2011]
- 034 Bone Marrow and Stem Cell Transplant Patients Share Their Stories [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- 035 Stem Cell Transplant India,Bone Marrow Transplant India,Sickle Cell Anemia Treatment India [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- 036 Bone Marrow Stem Cell Expansion by HOXB4 and p21 Knock Out [Last Updated On: September 21st, 2011] [Originally Added On: September 21st, 2011]
- 037 Multiple Sclerosis, Stem Cells, and Hope, Part 2 [Last Updated On: September 22nd, 2011] [Originally Added On: September 22nd, 2011]
- 038 Becoming a Blood Stem Cell Donor [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- 039 LittleBigPlanet 2 - Stem Cell Sackboy Quarter 4 Update (Bone Marrow Bugaloo) [Last Updated On: September 25th, 2011] [Originally Added On: September 25th, 2011]
- 040 Can Stem Cell Prolotherapy or Bone Marrow Prolotherapy help articular cartilage defects? [Last Updated On: September 27th, 2011] [Originally Added On: September 27th, 2011]
- 041 Mesenchymal stem cells and marrow stromal cells [Last Updated On: October 1st, 2011] [Originally Added On: October 1st, 2011]
- 042 Bone Marrow Transplant and Stem Cell Transplant Treatment in India for International patients [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 043 Bone Marrow Stem Cell Aspiration and Re-Injection with PRP for Osteoarthritis by Dr Adelson [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 044 Selected Donor for Stem Cell, Bone Marrow [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 045 Stem Cell Injections - Bone Marrow Prolotherapy - treatment for arthritis [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 046 Nurses Discuss Special Bonds With Bone Marrow and Stem Cell Transplant Patients [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 047 Hagen's bone marrow collection part 1 [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 048 Samsparks after bone marrow collection for stem cell treatm [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 049 Chat w/ Dr. Maharaj, founder of S. FL. Bone Marrow/Stem Cell Transplant Institute [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 050 Bone Marrow - Stem Cell Prolotherapy [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 051 MS Cure - Hickman line Insertion for stem cell/bone marrow transplant [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 052 Bone Marrow Transplant Program Continues to Grow, Make a Difference [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 053 Stem cell transplant in children: what to expect | Dana-Farber Cancer Institute [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 054 LittleBigPlanet 2 - (WIP) Stem Cell Sackboy Bone Marrow Bugaloo [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 055 Calum's stem cell donation for Anthony Nolan [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 056 Stem Cell Treatment in New Jersey- Colon's story (Dr Damon Noto) [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 057 How to be an Anthony Nolan blood stem cell donor [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 058 Dr Steve talks about stem cells.mov [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 059 Stem Cells extracted from bone marrow [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 060 Webinar 1, Stem cell therapy basics, what is available today? [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 061 Mesenchymal stem cells and marrow stromal cells---2nd--- [Last Updated On: October 8th, 2011] [Originally Added On: October 8th, 2011]
- 062 Harvesting stem cells from horse bone marrow at UT [Last Updated On: October 12th, 2011] [Originally Added On: October 12th, 2011]
- 063 Bone Marrow Stem Cells - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- 064 Stem Cell Transplant Apheresis Method - Video [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
- 065 Mantak Chia: Sumup stem cell (Berlin,Germany 2009) Part I : Bone marrow activate Stem cell - Video [Last Updated On: October 16th, 2011] [Originally Added On: October 16th, 2011]
- 066 Stem Cell, Bone Marrow Transplants / Donations - Easy and life saving proceedure - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 067 HIV/AIDS: Spotlight on Stem Cell Research - Loren Leeds - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 068 Sickle Cell Anemia: Stem Cell Gene Therapy - Donald Kohn - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 069 Do you need a large number of stem cells injected for Bone Marrow Prolotherapy to work? - Video [Last Updated On: October 23rd, 2011] [Originally Added On: October 23rd, 2011]
- 070 What are stem cells? - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- 071 What is in situ Stem Cell Injection Therapy or Bone Marrow Prolotherapy? - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- 072 Stem Cells Research at Hadassah - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- 073 Blood or Bone Marrow Cells May Provide a Route to Healing Blood Vessels - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- 074 Hematopoietic stem cell transplantation #2 - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- 075 Radiation - Sickle Cell Half Match Stem Cell Bone Marrow Transplant 2 - Video [Last Updated On: November 7th, 2011] [Originally Added On: November 7th, 2011]
- 076 Sickle Cell Stem Cell Bone Marrow Transplant 3 - Video [Last Updated On: November 7th, 2011] [Originally Added On: November 7th, 2011]
- 077 Macular degeneration - Stem Cell therapy (English subtitles) - Video [Last Updated On: November 13th, 2011] [Originally Added On: November 13th, 2011]
- 078 Where Do The Stem Cells Come From? Hollywood | Los Angeles - Video [Last Updated On: November 13th, 2011] [Originally Added On: November 13th, 2011]
- 079 Bone Marrow Stem Cell Injections - Video [Last Updated On: November 14th, 2011] [Originally Added On: November 14th, 2011]
- 080 Diabetes- Stem cell therapy (english) - Video [Last Updated On: December 2nd, 2011] [Originally Added On: December 2nd, 2011]
