TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously T...
August 13 2020 - 7:00AM
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that
the U.S. Food and Drug Administration (FDA) has accepted
the Company’s New Drug Application (NDA) for umbralisib, the
Company’s investigational once-daily, oral, dual inhibitor of
PI3K-delta and CK1-epsilon, as a treatment for patients with
previously treated marginal zone lymphoma (MZL) who have received
at least one prior anti-CD20 based regimen and follicular lymphoma
(FL) who have received at least two prior systemic therapies. The
MZL indication, under Breakthrough Therapy Designation (BTD), has
been accepted for Priority Review and has a Prescription Drug User
Fee Act (PDUFA) goal date of February 15, 2021. The FL indication
has been accepted for standard review with a PDUFA goal date of
June 15, 2021. The FDA also notified the Company that it is
not currently planning to hold an advisory committee meeting to
discuss this application.
Michael S. Weiss, Executive Chairman and Chief Executive Officer
of TG Therapeutics stated, "We are extremely pleased with the FDA’s
acceptance of our first NDA submission and look forward to working
with the FDA during the review process. This is a significant
achievement in our path towards accomplishing our goal of
developing novel treatments for patients with B-cell diseases.” Mr.
Weiss continued, “If approved, we believe umbralisib could become
an important treatment option for patients with previously treated
MZL and FL. We look forward to presenting the data from the
UNITY-NHL trial that supported this NDA submission by year
end.”
The NDA for umbralisib was based primarily on data from the
umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL Phase 2b
trial evaluating patients with relapsed/refractory MZL or FL. The
Company has previously announced that each cohort met its primary
endpoint of overall response rate (ORR), meeting the Company’s
target guidance of 40-50% ORR, as confirmed by an Independent
Review Committee (IRC). The FDA has also previously granted
umbralisib Breakthrough Therapy Designation (BTD) for MZL and
orphan drug designation (ODD) for MZL and FL.
ABOUT THE UNITY-NHL PHASE 2b STUDY—MZL & FL
COHORTS The UNITY- NHL trial is a global multicenter,
open-label Phase 2b trial.
The MZL cohort was designed to evaluate the safety and efficacy
of single agent umbralisib in patients with MZL who have
received at least one prior anti-CD20 regimen. In February of 2019,
the Company announced that the primary endpoint of overall response
rate (ORR) as determined by Independent Review Committee (IRC) was
met for all treated MZL patients. The results met the Company’s
target guidance of 40-50% ORR. Interim safety and efficacy data
from the MZL cohort were presented in oral presentations in 2019 at
the American Association for Cancer Research (AACR) annual meeting,
the American Society of Clinical Oncology (ASCO) annual meeting and
the International Conference on Malignant Lymphoma (ICML).
The FL cohort was designed to evaluate the safety and efficacy
of single agent umbralisib in patients with FL who were
relapsed or refractory following at least two prior lines of
therapy, including an anti-CD20 regimen and an alkylating agent. In
October of 2019, the Company announced that the primary endpoint of
ORR as determined by IRC was met for all treated FL patients. The
results met the Company’s prespecified response target of 40-50%
ORR.
On June 15, 2020, the Company announced the completion of the
rolling submission of a NDA to the FDA requesting accelerated
approval of umbralisib as a treatment for patients with previously
treated MZL and FL.
On August 12, 2020, the Company received notification from the
FDA of its acceptance of the Company’s NDA for umbralisib as a
treatment for patients with previously treated MZL and FL.
ABOUT MARGINAL ZONE LYMPHOMA Marginal zone
lymphoma (MZL) comprises a group of indolent (slow growing) mature
B-cell non-Hodgkin lymphomas (NHLs). MZL is generally considered a
chronic and incurable disease. With an annual incidence of
approximately 7,500 newly diagnosed patients in the United States1,
MZL is the third most common B-cell NHL, accounting for
approximately eight percent of all NHL cases. MZL consists of three
different subtypes: extranodal MZL of the mucosal-associated
lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and
splenic marginal zone lymphoma (SMZL)2.
ABOUT FOLLICULAR LYMPHOMA Follicular lymphoma
(FL) is typically an indolent form of non-Hodgkin lymphoma (NHL)
that arises from B-lymphocytes. It is the second most common
form of NHL. FL is generally not curable and is considered a
chronic disease, as patients can live for many years with this form
of lymphoma. With an annual incidence in the United
States of approximately 15,000 newly diagnosed patients3, FL
is the most common indolent lymphoma accounting for approximately
20 percent of all NHL cases4.
ABOUT TG THERAPEUTICS, INC.TG
Therapeutics is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel treatments
for B-cell malignancies and autoimmune diseases. Currently, the
company is in late stage clinical development with two
investigational compounds, ublituximab and umbralisib, the
combination of which is referred to as “U2”, targeting
hematological malignancies and autoimmune diseases. Ublituximab
(TG-1101) is a glycoengineered monoclonal antibody that targets a
specific and unique epitope on the CD20 antigen found on mature
B-lymphocytes. Umbralisib (TGR-1202) is an oral, once-daily
dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is
currently under review by the U.S. Food and Drug Administration
(FDA) for accelerated approval as a treatment for patients with
previously treated marginal zone lymphoma (MZL) who have received
at least one prior anti-CD20 based regimen or follicular lymphoma
(FL) who have received at least two prior systemic therapies. The
Company also has a fully enrolled Phase 3 clinical trial evaluating
U2 in patients with treatment naïve and relapsed/refractory chronic
lymphocytic leukemia (CLL), and two fully enrolled identical Phase
3 trials evaluating ublituximab monotherapy in patients with
relapsing forms of multiple sclerosis (RMS). Additionally, the
Company has recently brought into Phase 1 clinical development its
anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its
covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701,
as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG
Therapeutics is headquartered in New York City.
__________________________________________________
12016 Lymphoid Malignancy Statistics by World Health
Organization Subtypes VOLUME 66 _ NUMBER 6 _ NOVEMBER/DECEMBER
2016 https://onlinelibrary.wiley.com/doi/pdf/10.3322/caac.213572 Lymphoma
Research Foundation: Marginal Zone
Lymphoma https://lymphoma.org/aboutlymphoma/nhl/mzl/3 American
Cancer Society “Key Statistics for Non-Hodgkin
Lymphoma”4 Lymphoma Research Foundation “Follicular
Lymphoma”
Cautionary Statement This press release
contains forward-looking statements that involve a number of risks
and uncertainties. For those statements, we claim the protection of
the safe harbor for forward-looking statements contained in the
Private Securities Litigation Reform Act of 1995. In addition to
the risk factors identified from time to time in our reports filed
with the Securities and Exchange Commission, factors that
could cause our actual results to differ materially include the
following: the risk that umbralisib may not receive regulatory
approval for previously treated MZL or FL in the currently
anticipated timeline or at all; the risk that the FDA may grant
approval that is more restrictive than anticipated; our ability to
successfully launch umbralisib for previously treated MZL or FL, if
those indications are approved by the FDA; our ability to
successfully and cost-effectively complete our ongoing and planned
clinical trials; the risk that early clinical trial results (both
safety and efficacy), which may have influenced our decision to
proceed with additional clinical trials, will not be reproduced in
future studies; and the risk that the COVID-19 pandemic causes
unforeseen delays in the FDA timelines we have outlined or in our
ability to achieve other milestones we project. Any forward-looking
statements set forth in this press release speak only as of the
date of this press release. We do not undertake to update any of
these forward-looking statements to reflect events or circumstances
that occur after the date hereof. This press release and prior
releases are available at www.tgtherapeutics.com. The
information found on our website is not incorporated by reference
into this press release and is included for reference purposes
only.
CONTACT:
Jenna BoscoSenior Vice President,
Corporate CommunicationsTG Therapeutics, Inc.Telephone:
212.554.4351Email: ir@tgtxinc.com
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