G1 Therapeutics’ COSELA® (trilaciclib) Recommended in Updated Small Cell Lung Cancer Guidelines from the American Society of Clinical Oncology (ASCO)
October 18 2023 - 8:00AM
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today announced that COSELA® (trilaciclib) has been
recommended as a myeloid supportive agent in the updated American
Society of Clinical Oncology (ASCO) small cell lung cancer (SCLC)
guidelines for patients with untreated or previously treated
extensive-stage small cell lung cancer (ES-SCLC) who are undergoing
treatment with chemotherapy or chemoimmunotherapy. COSELA is
indicated to decrease the incidence of chemotherapy-induced
myelosuppression in adult patients when administered prior to a
platinum/etoposide-containing regimen or topotecan-containing
regimen for ES-SCLC.
“The inclusion of COSELA in these new ASCO SCLC guidelines is
essential, as they inform treatment decisions by U.S. physicians
caring for people living with small cell lung cancer,” said Raj
Malik, M.D., Chief Medical Officer of G1 Therapeutics. “The
mounting body of evidence from our clinical trials and real-world
studies demonstrates the potential of COSELA to protect the bone
marrow of patients with ES-SCLC against the harmful effects of
chemotherapy. These updated guidelines provide further clarity and
confidence to physicians considering cytotoxic therapies for their
patients with untreated and previously treated SCLC.”
Published on October 11, 2023, the SCLC guidelines, entitled
“Systemic Therapy for SCLC: ASCO-Ontario Health (Cancer Care
Ontario) Guideline” (Khurshid et al.) provide evidence-based
recommendations to practicing clinicians on the management of
patients with SCLC. ASCO’s clinical practice guidelines outline
appropriate methods of treatment and care for clinicians and
address specific clinical situations (disease-oriented) or the use
of approved medical products, procedures, or tests
(modality-oriented). Multidisciplinary panels of experts, including
patient advocates, develop ASCO’s clinical practice guidelines. For
more information on ASCO’s guidelines in thoracic cancer, including
the SCLC guidelines, please follow this link.
About COSELA®
(trilaciclib) for Injection
COSELA (trilaciclib) was approved by the U.S. Food and Drug
Administration on February 12, 2021.
Indication
COSELA® (trilaciclib) is indicated to decrease
the incidence of chemotherapy-induced myelosuppression in adult
patients when administered prior to a platinum/etoposide-containing
regimen or topotecan-containing regimen for extensive-stage small
cell lung cancer.
Important Safety Information
COSELA is contraindicated in patients with a history of serious
hypersensitivity reactions to trilaciclib.
Warnings and precautions include injection-site reactions
(including phlebitis and thrombophlebitis), acute drug
hypersensitivity reactions, interstitial lung disease
(pneumonitis), and embryo-fetal toxicity.
The most common adverse reactions (>10%) were fatigue,
hypocalcemia, hypokalemia, hypophosphatemia, aspartate
aminotransferase increased, headache, and pneumonia.
This information is not comprehensive. Please click here for
full Prescribing Information.
https://www.g1therapeutics.com/cosela/pi/
To report suspected adverse reactions, contact G1 Therapeutics
at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit
www.fda.gov/medwatch.
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 development plan
evaluating trilaciclib in a variety of solid tumors, including
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 X (formerly known as
Twitter) @G1Therapeutics and LinkedIn
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 the therapeutic potential of COSELA (trilaciclib)
and the degree the ASCO Guidelines inform treatment decisions by
U.S. physicians treating people living with small cell lung cancer,
are based on the company’s expectations and assumptions as of the
date of this press release. 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
(trilaciclib); 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 commercial-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 President, Investor Relations & Corporate
Communications919-907-1944 wroberts@g1therapeutics.com
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