Genmab A/S Genmab Announces That Janssen Has Received Positive Chmp Opinion For Rybrevant(R) (amivantamab) For Patients With Advanced Non-small Cell Lung Cancer With Egfr Exon 20 Insertion Mutations, After Failure Of Platinum-based Therapy
16 October 2021 - 4:05AM
UK Regulatory
TIDMGEN
Media Release
Copenhagen, Denmark, October 15, 2021
-- Janssen-Cilag International NV (Janssen) received a positive CHMP opinion
recommending conditional marketing authorization of amivantamab in Europe
for the treatment of adult patients with advanced non-small cell lung
cancer with activating epidermal growth factor receptor exon 20 insertion
mutations, after failure of platinum-based therapy
-- Represents First CHMP opinion for a DuoBody(R) product candidate
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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 the
granting of a conditional marketing authorization in Europe for
Janssen's amivantamab, a fully human bispecific antibody, for the
treatment of adult patients with advanced non-small cell lung
cancer (NSCLC) with activating epidermal growth factor receptor
(EGFR) exon 20 insertion mutations, after failure of platinum-based
therapy. In July 2012, Genmab entered into a collaboration with
Janssen Biotech, Inc. to create and develop bispecific antibodies
using Genmab's DuoBody technology platform. This is the first CHMP
opinion for a product that was created using Genmab's proprietary
DuoBody technology platform.
"Following the U.S. FDA approval of RYBREVANT(R) earlier this
year, we are extremely pleased that the CHMP has granted Janssen a
positive opinion for amivantamab, the first such opinion for a
product created using Genmab's DuoBody technology platform. We are
hopeful that this opinion will lead to an approval and to the first
treatment option for European patients with advanced NSCLC with
activating EGFR exon 20 insertion mutations," said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab.
For more information related to Janssen's CHMP opinion for
amivantamab, click he
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About Genmab
Genmab is an international biotechnology company with a core
purpose to improve the lives of people with cancer. For more than
20 years, Genmab's vision to transform cancer treatment has driven
its passionate, innovative and collaborative teams to invent
next-generation antibody technology platforms and leverage
translational research and data sciences, fueling multiple
differentiated cancer treatments that make an impact on people's
lives. To develop and deliver novel therapies to patients, Genmab
has formed 20+ strategic partnerships with biotechnology and
pharmaceutical companies. Genmab's proprietary pipeline includes
bispecific T-cell engagers, next-generation immune checkpoint
modulators, effector function enhanced antibodies and antibody-drug
conjugates.
Genmab 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
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and follow us on Twitter.com/Genmab
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.
Contact:
Marisol Peron, Senior Vice President, Global Investor Relations
& Communications
T: +1 609 524 0065; E: mmp@genmab.com
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For Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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This Media Release 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
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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
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www.sec.gov. Genmab does not undertake any obligation to update or
revise forward looking statements in this Media Release 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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination
with the Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ; DuoBody
in combination with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in
combination with the HexaBody logo(R) ; DuoHexaBody(R) ;
HexElect(R) ; and UniBody(R) . RYBREVANT(R) is a trademark of
Johnson & Johnson.
Media Release no. 12
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 151021_i12_Amivantamab CHMP
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(END) Dow Jones Newswires
October 15, 2021 13:05 ET (17:05 GMT)
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