DJ EQS-News: Antengene Submits NDAs for XPOVIO(R) (Selinexor) in Multiple APAC Markets for rrMM and rrDLBCL
EQS-News / 03/12/2020 / 17:27 UTC+8
Antengene Submits NDAs for XPOVIO(R) (Selinexor) in Multiple APAC Markets
for rrMM and rrDLBCL
Shanghai and Hong Kong, PRC, December 3, 2020-- Antengene Corporation
Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical
company dedicated to discovering, developing and commercializing global
first-in-class and/or best-in class therapeutics in hematology and oncology,
announced it has submitted new drug applications ("NDA(s)") for XPOVIO(R)
(selinexor, ATG-010) to the Health Sciences Authority of Singapore and to
the Australian Therapeutic Goods Administration for three indications: the
treatment of adult patients with relapsed or refractory multiple myeloma
("rrMM") who have received at least four prior therapies and whose disease
is refractory to at least two proteasome inhibitors, at least two
immunomodulatory agents, and an anti-CD38 monoclonal antibody; and in
combination with bortezomib and dexamethasone for the treatment of patients
with multiple myeloma who have received at least one prior line of therapy;
and for the treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma ("rrDLBCL"), not otherwise specified, including DLBCL
arising from follicular lymphoma, after at least two lines of systemic
therapy. Australian Therapeutic Goods Administration has accepted the NDA of
Antengene on December 2, 2020.
A new drug application (NDA) for XPOVIO(R) (selinexor) has also been
submitted to the Hong Kong Department of Health for the treatment of adult
patients with rrMM who have received at least four prior therapies and whose
disease is refractory to at least two proteasome inhibitors, at least two
immunomodulatory agents, and an anti-CD38 monoclonal antibody.
In South Korea, XPOVIO(R) (selinexor) has been granted orphan drug
designation for the treatment of adult patients with rrMM who have received
at least four prior therapies and whose disease is refractory to at least
two proteasome inhibitors, at least two immunomodulatory agents, and an
anti-CD38 monoclonal antibody and for the treatment of adult patients with
rrDLBCL, not otherwise specified, including DLBCL arising from follicular
lymphoma, after at least two lines of systemic therapy.
XPOVIO(R) (selinexor, ATG-010) is a first-in-class and only-in-class oral
selective inhibitor of nuclear export, developed by Antengene and Karyopharm
Therapeutics Inc. (NASDAQ: KPTI). In July 2019, the US Food and Drug
Administration (FDA) approved XPOVIO(R) (selinexor) in combination with
low-dose dexamethasone for the treatment of rrMM. After its initial approval
of rrMM, FDA approved XPOVIO(R) (selinexor) as a single-agent for the
treatment of rrDLBCL in June 2020.
In November 2020, at the Connective Tissue Oncology Society 2020 Annual
Meeting (CTOS 2020), Antengene's partner, Karyopharm Therapeutics, presented
positive results from the Phase 3 portion of the randomized, double blind,
placebo controlled, cross-over SEAL study evaluating single agent, oral
XPOVIO(R) (selinexor) versus matching placebo in patients with liposarcoma.
Karyopharm also recently announced that the ongoing phase 3 SIENDO study of
XPOVIO(R) (selinexor) in patients with endometrial cancer passed planned
interim futility analysis and that Data and Safety Monitoring Board (DSMB)
recommended the study should proceed as planned without any modifications.
Top-line SIENDO study results are expected in the second half of 2021.
About XPOVIO(R)
XPOVIO(R) is a first-in-class and only-in-class oral selective inhibitor of
nuclear export compound, developed by Antengene and Karyopharm Therapeutics
Inc. (NASDAQ: KPTI). In July 2019, the US Food and Drug Administration (FDA)
approved XPOVIO(R) in combination with low-dose dexamethasone for the
treatment of relapsed or refractory multiple myeloma (rrMM) and in June 2020
approved XPOVIO(R) as a single-agent for the treatment of relapsed or
refractory diffuse large B-cell lymphoma (rrDLBCL). XPOVIO(R) is so far the
first and only oral SINE compound approved by the FDA. XPOVIO(R) is also
being evaluated in several other mid-and later-phase clinical trials across
multiple solid tumor indications, including liposarcoma and endometrial
cancer.
Antengene is conducting two registrational Phase 2 clinical trials of
XPOVIO(R) in China for relapsed refractory multiple myeloma (MARCH) and for
relapsed refractory diffuse large B-cell lymphoma (SEARCH), and has
initiated clinical trials for high prevalence cancer types in the Asia
Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma
(TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading
clinical-stage Asia-Pacific biopharmaceutical company focused on innovative
oncology medicines. Antengene aims to provide the most advanced anti-cancer
drugs to patients in China, the Asia Pacific Region and around the world.
Since its establishment, Antengene has built a pipeline of 12 clinical and
pre-clinical stage assets, obtained 10 investigational new drug approvals
and has 9 ongoing cross-regional clinical trials in Asia Pacific. The vision
of Antengene is to "Treat Patients Beyond Borders". Antengene aims to
address significant unmet medical needs by discovering, developing and
commercializing first-in-class/best-in-class therapeutics.
Forward-looking statements
The forward-looking statements made in this article relate only to the
events or information as of the date on which the statements are made in
this article. Except as required by law, we undertake no obligation to
update or revise publicly any forward-looking statements, whether as a
result of new information, future events or otherwise, after the date on
which the statements are made or to reflect the occurrence of unanticipated
events. You should read this article completely and with the understanding
that our actual future results or performance may be materially different
from what we expect. In this article, statements of, or references to, our
intentions or those of any of our Directors or our Company are made as of
the date of this article. Any of these intentions may alter in light of
future development.
* XPOVIO(R) is a registered trademark of Karyopharm Therapeutics Inc.
File: Antengene Submits NDAs for XPOVIO(R) (Selinexor) in Multiple APAC
Markets for rrMM and rrDLBCL [1]
03/12/2020 Dissemination of a Marketing Press Release, transmitted by EQS
Group.
The issuer is solely responsible for the content of this announcement.
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(END) Dow Jones Newswires
December 03, 2020 04:27 ET (09:27 GMT)
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