RESEARCH TRIANGLE PARK, N.C., Oct. 18, 2023 (GLOBE NEWSWIRE) — 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.
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“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 Therapeutics
G1 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 Roberts
Vice President, Investor Relations & Corporate Communications
919-907-1944
wroberts@g1therapeutics.com
