G1 Therapeutics Receives Fast Track Designation from U.S. Food and Drug Administration for COSELA™ (Trilaciclib) in Combina...
July 19 2021 - 9:20AM
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation to COSELA™ (trilaciclib)
investigation for use in combination with chemotherapy for the
treatment of locally advanced or metastatic triple negative breast
cancer (TNBC). COSELA is currently being evaluated in PRESERVE 2, a
pivotal Phase 3, randomized, double-blind, placebo-controlled study
(NCT04799249) in patients receiving first- or second-line
gemcitabine and carboplatin chemotherapy for TNBC. (press release)
Fast track is a process designed to facilitate the development
and expedite the review of drugs to treat serious conditions and
fill unmet medical needs. The purpose is to get important new drugs
to the patient earlier. A drug that receives Fast Track designation
may be eligible for more frequent engagements with the FDA to
discuss the drug’s clinical development plan, eligibility for
Accelerated Approval and Priority Review, and Rolling Review in
which the Company can submit completed sections of its New Drug
Application (NDA) for FDA review rather than waiting until every
section of the NDA is completed before the entire application can
be reviewed.
“Fast Track designation underscores the urgent need for
innovative drugs that can significantly improve TNBC patient
outcomes,” said Raj Malik, M.D., Chief Medical Officer at G1
Therapeutics. “It provides an important pathway to help expedite
the development and regulatory review of COSELA in this indication.
We look forward to working closely with the FDA as we advance this
pivotal program in TNBC and continue to work to unlock the broader
potential of this pipeline-in-a-molecule compound that we hope will
help patients across multiple tumor types.”
About Triple Negative Breast Cancer
(TNBC)According to the American Cancer Society, nearly
300,000 new cases of invasive breast cancer are diagnosed annually
in the U.S. Triple-negative breast cancer makes up approximately
15% to 20% of such diagnosed breast cancers. TNBC is cancer that
tests negative for estrogen receptors, progesterone receptors, and
excess HER2 protein. Because TNBC cells lack key growth-signaling
receptors, patients do not respond well to medications that block
estrogen, progesterone, or HER2 receptors. Instead, treating TNBC
typically involves chemotherapy, radiation, and surgery. TNBC is
considered to be more aggressive and have a poorer prognosis than
other types of breast cancer. In general, survival rates tend to be
lower with TNBC compared to other forms of breast cancer, and TNBC
is also more likely than some other types of breast cancer to
return after it has been treated, especially in the first few years
after treatment. It also tends to be higher grade than other types
of breast cancer.
About G1 TherapeuticsG1 Therapeutics, Inc. is a
commercial-stage biopharmaceutical company focused on the
development and commercialization of next generation therapies that
improve the lives of those affected by cancer, including the
Company’s first commercial product, COSELA™ (trilaciclib). G1 has a
deep clinical pipeline and is executing a tumor-agnostic
development plan evaluating COSELA in a variety of solid tumors,
including colorectal, breast, lung, and bladder cancers. G1
Therapeutics is based in Research Triangle Park, N.C. For
additional information, please visit www.g1therapeutics.com and
follow us on Twitter @G1Therapeutics.
G1 Therapeutics™ and the G1 Therapeutics logo and COSELA™ and
the COSELA logo are trademarks of G1 Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "expect," "plan," "anticipate,"
"estimate," "intend" and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
Forward-looking statements in this press release include, but are
not limited to, COSELA’s (trilaciclib) possibility to improve
patient outcomes in this Phase 3 trial of COSELA in metastatic
triple negative breast cancer and in our other investigative
trials, these trials may or may not result in endpoints that
achieve statistical significance, and the safety and effectiveness
of COSELA in this treatment regimen and the other treatment
regimens we are investigating have not been yet determined nor
approved by the FDA. Each of these forward-looking statements
involves risks and uncertainties. Factors that may cause the
company’s actual results to differ from those expressed or implied
in the forward-looking statements in this press release are
discussed in the company’s filings with the U.S. Securities
and Exchange Commission, including the "Risk Factors" sections
contained therein and include, but are not limited to, the
company’s dependence on the commercial success of COSELA; the
development and commercialization of new drug products is highly
competitive; the company’s ability to complete clinical trials for,
obtain approvals for and commercialize any of its product
candidates; the company’s initial success in ongoing clinical
trials may not be indicative of results obtained when these trials
are completed or in later stage trials; the inherent uncertainties
associated with developing new products or technologies and
operating as a development-stage company; and market conditions.
Except as required by law, the company assumes no obligation to
update any forward-looking statements contained herein to reflect
any change in expectations, even as new information becomes
available.
G1 Therapeutics Contacts:
Will RobertsVice PresidentInvestor Relations and Corporate
Communications(919) 907-1944 wroberts@g1therapeutics.com
Rebecca LevineDirector, Corporate Communications and Public
Relations(919) 667-8711 rlevine@g1therapeutics.com
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