On October 18, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that COSELA (trilaciclib) has been recommended as a myeloid supportive agent in the updated American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 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 (Press release, G1 Therapeutics, OCT 18, 2023, View Source [SID1234636107]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The inclusion of COSELA in these new ASCO (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper)-Ontario Health (Cancer Care Ontario) Guideline" (Khurshid et al.) provide evidence-based recommendations to practicing clinicians on the management of patients with SCLC. ASCO (Free ASCO Whitepaper)’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 (Free ASCO Whitepaper)’s clinical practice guidelines. For more information on ASCO (Free ASCO Whitepaper)’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. View Source

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.