Company Announcement
- U.S. FDA grants Priority Review to daratumumab in
combination with lenalidomide and dexamethasone, or bortezomib and
dexamethasone for relapsed multiple myeloma - February 17, 2017
PDUFA date
- U.S. FDA grants Standard Review to daratumumab in
combination with pomalidomide and dexamethasone for relapsed or
refractory multiple myeloma - June 17, 2017 PDUFA
date
COPENHAGEN, Denmark, Oct. 7, 2016 (GLOBE NEWSWIRE)
-- Genmab A/S (Nasdaq Copenhagen: GEN) announced today
that the U.S. Food and Drug Administration (FDA) has granted
Priority Review to the supplemental Biologics License Application
(sBLA) for the use of daratumumab (DARZALEX(r)) 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. The sBLA was
submitted by Genmab's licensing partner, Janssen Biotech, Inc. in
August 2016. Priority Review is an FDA designation for drugs that
treat a serious condition and may provide a significant improvement
in safety or efficacy. The FDA has assigned a Prescription
Drug User Fee Act (PDUFA) target date of February 17, 2017 to take
a decision on daratumumab in this indication. In addition,
the FDA has granted a Standard Review period for the use of
daratumumab in combination with pomalidomide and dexamethasone for
the treatment of patients with relapsed or refractory multiple
myeloma who have received at least two prior therapies, with a
proteasome inhibitor and an immunomodulatory agent. The PDUFA
date for the combination of daratumumab with
pomalidomide/dexamethasone is June 17, 2017.
The FDA granted a Breakthrough Therapy Designation for
daratumumab 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
July 2016.
"People suffering from multiple myeloma always ultimately
relapse after receiving treatment with the therapies available
today. The application for daratumumab in combination with
current backbone therapies for patients who have already received
at least one type of treatment is a key step towards trying to
bring new treatment options to patients with multiple myeloma,"
said Jan van de Winkel, Ph.D., Chief Executive Officer of
Genmab.
The sBLA submission included data from two Phase III studies:
the CASTOR study of daratumumab in combination with bortezomib and
dexamethasone versus bortezomib and dexamethasone alone in patients
with relapsed or refractory multiple myeloma, and the POLLUX study
of daratumumab in combination with lenalidomide and dexamethasone
versus lenalidomide and dexamethasone alone in patients with
relapsed or refractory multiple myeloma. The submission also
included data from the Phase I study of daratumumab in combination
with pomalidomide and dexamethasone in relapsed or refractory
multiple myeloma.
About multiple myeloma Multiple myeloma is an
incurable blood cancer that starts in the bone marrow and is
characterized by an excess proliferation of plasma cells.1 Multiple
myeloma is the third most common blood cancer in the U.S., after
leukemia and lymphoma.2 Approximately 30,330 new patients are
expected to be diagnosed with multiple myeloma and approximately
12,650 people are expected to die from the disease in the U.S. in
2016.3 Globally, it was estimated that 124,225 people would be
diagnosed and 87,084 would die from the disease in 2015.4
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.5 Patients who relapse after treatment with standard
therapies, including proteasome inhibitors or immunomodulatory
agents, have poor prognoses and few treatment options.6
About DARZALEX (r)
(daratumumab) DARZALEX(r) (daratumumab) injection
for intravenous infusion is indicated in the United States for the
treatment of patients with multiple myeloma who have received at
least three prior lines of therapy, including a proteasome
inhibitor (PI) and an immunomodulatory agent, or who are
double-refractory to a PI and an immunomodulatory agent.7DARZALEX
is the first monoclonal antibody (mAb) to receive U.S. Food and
Drug Administration (FDA) approval to treat multiple myeloma.
DARZALEX is indicated in Europe for use 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
therapy. For more information, visit
www.DARZALEX.com.
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. It is believed
to induce rapid tumor cell death through programmed cell death, or
apoptosis,7,8 and multiple immune-mediated mechanisms, including
complement-dependent cytotoxicity,7,8 antibody-dependent cellular
phagocytosis9,10 and antibody-dependent cellular
cytotoxicity.7,8 In addition, daratumumab therapy results in
a reduction of immune-suppressive myeloid derived suppressor cells
(MDSCs) and subsets of regulatory T cells (Tregs) and B cells
(Bregs), all of which express CD38. These reductions in MDSCs,
Tregs and Bregs were accompanied by increases in CD4+ and CD8+ T
cell numbers in both the peripheral blood and bone
marrow.7,11
Daratumumab is being developed by Janssen Biotech, Inc. under an
exclusive worldwide license to develop, manufacture and
commercialize daratumumab from Genmab. Five Phase III clinical
studies with daratumumab in relapsed and frontline settings are
currently ongoing, and additional studies are ongoing or planned to
assess its potential in other malignant and pre-malignant diseases
on which CD38 is expressed, such as smoldering myeloma,
non-Hodgkin's lymphoma and a solid tumor.
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, Arzerra(r) (ofatumumab) for the treatment of
certain chronic lymphocytic leukemia indications and DARZALEX(r)
(daratumumab) for the treatment of heavily pretreated or double
refractory multiple myeloma. Daratumumab is in clinical development
for additional multiple myeloma indications and for non-Hodgkin's
lymphoma. 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(r)
platform for generation of bispecific antibodies, and the
HexaBody(r) platform which creates effector function enhanced
antibodies. 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. For more information visit
www.genmab.com.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations
& Communications T: +45 33 44 77 20; M: +45 25 12 62 60;
E: r.gravesen@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 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 . Genmab does not undertake any obligation to update
or revise forward looking statements in this Company Announcement
nor to confirm such statements in relation to actual results,
unless required by law.
Genmab A/S and its subsidiaries own the following trademarks:
Genmab(r); the Y-shaped Genmab logo(r); Genmab in combination with
the Y-shaped Genmab logo(tm); the DuoBody logo(r); the HexaBody
logo(tm); HuMax(r); HuMax-CD20(r); DuoBody(r); HexaBody(r) and
UniBody(r). Arzerra(r) is a trademark of Novartis AG or its
affiliates. DARZALEX(r) is a trademark of Janssen Biotech, Inc.
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 National Cancer Institute. "A Snapshot
of Myeloma." Available at
www.cancer.gov/research/progress/snapshots/myeloma. Accessed June
2016. 3 American Cancer Society. "What are the key statistics
about multiple myeloma?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-key-statistics.
Accessed June 2016. 4 GLOBOCAN 2012: Estimated Cancer
Incidence, Mortality and Prevalence Worldwide: Number of New
Cancers in 2015. Available at:
http://globocan.iarc.fr/old/burden.asp?selection_pop=224900&Text-p=World&selection_cancer=17270&Text-c=Multiple+myeloma&pYear=3&type=0&window=1&submit=%C2%A0Execute.
Accessed June 2016. 5 American Cancer Society. "How is
Multiple Myeloma Diagnosed?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis.
Accessed June 2016. 6 Kumar, SK et al. Risk of progression and
survival in multiple myeloma relapsing after last therapy with
IMiDs and bortezomib: a multicenter international myeloma working
group study. Leukemia. 2012; 26:149-57. 7 DARZALEX US Prescribing
Information, November 2015. 8 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 Khagi, Y and
Mark, TM. Potential role of daratumumab in the treatment of
multiple myeloma. Onco Targets Ther. 2014; 7: 1095-1100. 11
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.
Company Announcement no. 49 CVR no. 2102 3884
Genmab A/S Bredgade 34E 1260 Copenhagen K Denmark
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