Company Announcement
- DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
approved by U.S. FDA as the first and only therapy for newly
diagnosed Light-chain (AL) amyloidosis
- Accelerated
approval of DARZALEX FASPRO-based combination regimen supported by
the Phase 3 ANDROMEDA (AMY3001) study
- Genmab to
receive USD 30 million milestone payment on first commercial
sale
Copenhagen, Denmark; January 15, 2021 –
Genmab A/S (Nasdaq: GMAB) announced today that the U.S.
Food and Drug Administration (U.S. FDA) has approved the use of
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a
subcutaneous formulation of daratumumab, in combination with
bortezomib, cyclophosphamide, and dexamethasone (VCd) for the
treatment of adult patients with newly diagnosed light-chain (AL)
amyloidosis. A supplemental Biologics License Application
(sBLA) for this indication was submitted by Janssen Biotech, Inc.
(Janssen), in September 2020. The U.S. FDA reviewed the submission
of data for approval in this indication under their Real-Time
Oncology Review (RTOR)1 pilot program and Project Orbis2. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial(s).
DARZALEX FASPRO is not indicated and is not recommended for the
treatment of patients with light-chain (AL) amyloidosis who have
NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB
outside of controlled clinical trials. In August 2012, Genmab
granted Janssen an exclusive worldwide license to develop,
manufacture and commercialize daratumumab.
“AL amyloidosis is a devastating and potentially fatal blood
disorder that, until now, did not have any U.S. FDA-approved
therapies. This makes today’s approval of DARZALEX FASPRO a
critical step forward for patients in the U.S. in dire need of
treatment options,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab.
The approval was based on data from the Phase 3 ANDROMEDA
(AMY3001) study of daratumumab and hyaluronidase-fihj in
combination with VCd as treatment for patients with newly diagnosed
AL amyloidosis.
The most common adverse reactions (≥20%) were upper respiratory
tract infection, diarrhea, peripheral edema, constipation, fatigue,
peripheral sensory neuropathy, nausea, insomnia, dyspnea and cough.
Serious adverse reactions occurred in 43% of patients who received
DARZALEX FASPRO in combination with VCd. Serious adverse reactions
that occurred in at least 5% of patients in the D-VCd arm were
pneumonia (9%), cardiac failure (8%) and sepsis (5%). Fatal adverse
reactions occurred in 11% of patients. Fatal adverse reactions that
occurred in more than one patient included cardiac arrest (4%),
sudden death (3%), cardiac failure (3%) and sepsis (1%).3
Among patients who received DARZALEX FASPRO in combination with
VCd, 72% of patients had baseline cardiac involvement with Mayo
Cardiac Stage I (3%), Stage II (46%) and Stage III (51%). Serious
cardiac disorders occurred in 16% of patients (8% of patients with
Mayo Cardiac Stage I and II and 28% of patients with Stage III).
Serious cardiac disorders in more than 2% of patients included
cardiac failure (8%), cardiac arrest (4%) and arrhythmia (4%).
Fatal cardiac disorders occurred in 10% of patients (5% of patients
with Mayo Cardiac Stage I and II and 19% of patients with Stage
III) who received DARZALEX FASPRO in combination with VCd. Fatal
cardiac disorders that occurred in more than one patient in the
D-VCd arm included cardiac arrest (4%), sudden death (3%) and
cardiac failure (3%).3
Full prescribing information will be available at
www.DARZALEX.com.Genmab will receive a milestone payment of USD 30
million in connection with the first commercial sale of DARZALEX
FASPRO in this indication, which is expected to occur quickly after
approval. The milestone will be reflected in Genmab’s 2021
guidance, which will be published on February 23, 2021.
About the ANDROMEDA (AMY3001) studyThe Phase 3
study (NCT03201965) included 388 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 Light-chain (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. Until
now there were no approved therapies for AL amyloidosis in the
U.S., though it is currently being treated with chemotherapy,
dexamethasone, stem cell transplants and supportive therapies.4 It
is estimated that there are approximately 3,000 to 4,000 new cases
of AL amyloidosis diagnosed annually in the U.S.5
About DARZALEX®
(daratumumab)DARZALEX® (daratumumab) has become a
backbone therapy in the treatment of multiple myeloma. DARZALEX
intravenous infusion is indicated for the treatment of adult
patients in the United States: in combination with carfilzomib and
dexamethasone for the treatment of patients with
relapsed/refractory multiple myeloma who have received one to three
previous lines of therapy; 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.6 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 for the treatment of adult patients in
Europe via intravenous infusion or subcutaneous administration: 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 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 therapy7. Daratumumab
is the first subcutaneous CD38 antibody approved in Europe for the
treatment of multiple myeloma. 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 intravenous infusion is approved for the
treatment of adult patients: 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 relapsed or
refractory multiple myeloma. DARZALEX is the first human CD38
monoclonal antibody to reach the market in the United States,
Europe and Japan. For more information, visit www.DARZALEX.com.
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a
subcutaneous formulation of daratumumab, is approved in the United
States for the treatment of adult patients with newly diagnosed
light-chain (AL) amyloidosis in combination with bortezomib,
cyclophosphamide, and dexamethasone. It is also approved in the
U.S. for the treatment of adult patients with multiple myeloma: in
combination with bortezomib, thalidomide, and dexamethasone in
newly diagnosed patients who are eligible for ASCT; in combination
with bortezomib, melphalan and prednisone in newly diagnosed
patients who are ineligible for ASCT; in combination with
lenalidomide and dexamethasone in newly diagnosed patients who are
ineligible for ASCT and in patients with relapsed or refractory
multiple myeloma who have received at least one prior therapy; in
combination with bortezomib and dexamethasone in patients who have
received at least one prior therapy; and as monotherapy, in
patients 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.8 DARZALEX
FASPRO is co-formulated with recombinant human hyaluronidase PH20
(rHuPH20), Halozyme's ENHANZE® drug delivery technology. .DARZALEX
FASPRO is the first subcutaneous CD38 antibody approved in the U.S.
for the treatment of multiple myeloma and the first and only
approved treatment for patients with AL amyloidosis in the U.S.
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).6,9,10,11,12
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 and T-cell acute lymphocytic leukemia (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 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, 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 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® and DARZALEX
FASPRO® are trademarks of Janssen Pharmaceutica NV.
1 Real-Time Oncology Review Pilot Program.
https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program
Accessed September 20202 Project Orbis. U.S. Food and Drug
Administration.
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis.
Accessed September 2020.3DARZALEX FASPRO® Prescribing Information.
Horsham, PA: Janssen Biotech, Inc.4 Mayo Clinic website:
www.mayoclinic.com/health/amyloidosis/DS004315 Research and
Markets, “Amyloidosis Treatment Market Size, Share & Trends
Analysis Report by Treatment (Stem Cell Transplant, Chemotherapy,
Supportive Care, Surgery, Targeted Therapy), By Country, And
Segment Forecasts, 2018 - 20256 DARZALEX Prescribing information,
August 2020
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s029lbl.pdf
Last accessed August 20207 DARZALEX Summary of Product
Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed June 20208 DARZALEX FASPRO Prescribing information, May
2020. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf
Last accessed May 20209 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: 1840-1848.10 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: 311-21.11 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: 384-94.12 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. 03CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 150121_CA03_ANDROMEDA FDA Approval
Genesis Healthcare (NYSE:GEN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Genesis Healthcare (NYSE:GEN)
Historical Stock Chart
From Apr 2023 to Apr 2024