Company Announcement
- Janssen received
a positive CHMP opinion
for DARZALEX®
SC (daratumumab and
hyaluronidase-fihj) in combination with
bortezomib, cyclophosphamide and dexamethasone for
the treatment of adult patients
with newly diagnosed systemic
light-chain (AL) amyloidosis
- Opinion based on data from the Phase 3
ANDROMEDA (AMY3001)
study
- CHMP also issued a
positive opinion recommending
DARZALEX® SC in combination with
pomalidomide and dexamethasone for adult
patients with relapsed or refractory multiple myeloma,
based on the Phase 3 APOLLO (MMY3013) study
Copenhagen, Denmark; May
21, 2021
– Genmab A/S
(Nasdaq:
GMAB) announced today
that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has adopted
a positive opinion and recommended granting
marketing authorization for the
daratumumab subcutaneous (SC) formulation
(daratumumab and
hyaluronidase-fihj), known as
DARZALEX® SC
in the European Union, in
combination with
bortezomib, cyclophosphamide,
and dexamethasone (VCd) for the treatment of adult
patients with newly diagnosed
systemic light-chain (AL)
amyloidosis. The CHMP also issued a positive opinion
recommending DARZALEX SC in combination with pomalidomide and
dexamethasone (Pd) for the treatment of adult patients with
multiple myeloma who have received one prior therapy containing a
proteasome inhibitor (PI) and lenalidomide and were lenalidomide
refractory, or who have received at least two prior therapies that
included lenalidomide and a PI and have demonstrated disease
progression on or after the last therapy. Janssen Pharmaceutica NV
submitted Type II variation applications to the EMA for these
indications in November 2020. In August 2012, Genmab granted
Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to
develop, manufacture and commercialize daratumumab.
“We are extremely pleased about the positive CHMP opinions for
DARZALEX SC and hopeful that the positive opinion in AL amyloidosis
will lead to the first approved treatment option for European
patients with this devastating disease,” said Jan van de Winkel,
Ph.D., Chief Executive Officer of Genmab.
About the ANDROMEDA (AMY3001) studyThe Phase 3
study (NCT03201965) included 416 patients newly diagnosed with AL
amyloidosis. Patients were randomized to receive treatment with
either daratumumab and hyaluronidase-fihj in combination with
bortezomib (a proteasome inhibitor), cyclophosphamide (a
chemotherapy), and dexamethasone (a corticosteroid) or treatment
with VCd alone. The primary endpoint of the study was the
percentage of patients who achieve hematologic complete
response.
About the APOLLO (MMY3013)
studyThe Phase 3 (NCT03180736), randomized, open-label,
multicenter study included 304 patients with multiple myeloma who
have previously been treated with lenalidomide and a PI. Patients
were randomized 1:1 to either receive daratumumab in combination
with Pd or Pd alone. In the original design of the study, patients
in the daratumumab plus Pd arm were treated with the intravenous
(IV) formulation of daratumumab. As of Amendment 1 to the study
protocol, all new subjects in the experimental arm were dosed with
the SC formulation of daratumumab and patients who had already
begun treatment with IV daratumumab had the option to switch to the
SC formulation. The primary endpoint of the study was progression
free survival (PFS). The study was conducted in Europe under an
agreement between Janssen, the European Myeloma Network (EMN) and
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON).
About AL
AmyloidosisAmyloidosis is a disease that occurs
when amyloid proteins, which are abnormal proteins, accumulate in
tissues and organs. When the amyloid proteins cluster together,
they form deposits that damage the tissues and organs. AL
amyloidosis most frequently affects the heart, kidneys, liver,
nervous system and digestive tract. There is currently no cure for
AL amyloidosis or existing approved therapies for AL amyloidosis
patients in Europe, though it can be treated with chemotherapy,
dexamethasone, stem cell transplants and supportive therapies.1 It
is estimated that in 2019 there were 4,388 diagnosed incident cases
of AL amyloidosis in the five major European markets.2
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.3
Approximately 18,114 new patients were diagnosed with multiple
myeloma and approximately 11,063 people died from the disease in
the Western Europe in 2020.4 Globally, it was estimated that
176,404 people were diagnosed and 117,077 died from the disease in
2020.5 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.6
About DARZALEX®
SC (daratumumab and
hyaluronidase-fihj)Daratumumab is being developed by
Janssen Biotech, Inc. under an exclusive worldwide license to
develop, manufacture and commercialize daratumumab from Genmab.
DARZALEX® SC (daratumumab and hyaluronidase-fihj) is the first
subcutaneous CD38 antibody approved in the Europe for the treatment
of multiple myeloma. 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 person’s 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). 7,8, 9, 10, 11
For the full EU Summary of Product Characteristics, please click
here.
About Genmab Genmab is an international
biotechnology company with a core purpose to improve the lives of
patients with cancer. Founded in 1999, Genmab is the creator of
multiple approved antibody therapeutics that are marketed by its
partners. The company aims to create, develop and commercialize
differentiated therapies by leveraging next-generation antibody
technologies, expertise in antibody biology, translational research
and data sciences and strategic partnerships. To create novel
therapies, Genmab utilizes its next-generation antibody
technologies, which are the result of its collaborative company
culture and a deep passion for innovation. Genmab’s proprietary
pipeline consists of modified antibody candidates, including
bispecific T-cell engagers and next-generation immune checkpoint
modulators, effector function enhanced antibodies and antibody-drug
conjugates. The company is headquartered in Copenhagen, Denmark
with locations in Utrecht, the Netherlands, Princeton, New Jersey,
U.S. and Tokyo, Japan. For more information, please visit
Genmab.com.
Contact: Marisol
Peron, Senior Vice President, Global Investor Relations &
CommunicationsT: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Vice
President, Head of 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 Genmab’s most recent financial reports, which are
available on www.genmab.com and the risk factors included in
Genmab’s most recent Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange Commission (SEC), which are
available at 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®. DARZALEX® is a trademark of
Johnson & Johnson.
1 Mayo Clinic website:
www.mayoclinic.com/health/amyloidosis/DS004312 Global Data,
“Amyloidosis: Epidemiology Forecast to 2029,” June 20203 American
Cancer Society. "What is Multiple Myeloma." Available at
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed
May 2021.4 Globocan 2020. Western Europe Fact Sheet. Available at
http://gco.iarc.fr/today/data/factsheets/populations/926-western-europe-fact-sheets.pdf
Accessed May 20215 Globocan 2018. World Fact Sheet. Available at
https://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf
Accessed May 20216 American Cancer Society. "Sings and Symptoms of
Multiple Myeloma"
https://www.cancer.org/cancer/multiple-myeloma/detection-diagnosis-staging/signs-symptoms.html.
Accessed May 20217 DARZALEX Prescribing information, March 2021
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761036s033lbl.pdf
Last accessed May 20218 De 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: 1840-1848.9 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: 311-21.10 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: 384-94.11 Jansen, 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. 45CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 210521_CA45_DARZALEX SC CHMP
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