After 13 years as a clinical-stage oncology company, G1 Therapeutics of Research Triangle Park transformed into a commercial-stage company overnight upon the approval of its first drug by the U.S. Food and Drug Administration.
The FDA on Feb. 12 approved G1’s trilaciclib, to be marketed as Cosela, for protecting bone marrow from chemotherapy damage in adult patients with extensive-stage small cell lung cancer (ES-SCLC).
“Cosela will help change the chemotherapy experience for people who are battling ES-SCLC,” said Jack Bailey, the company’s chief executive officer. “G1 is proud to deliver Cosela to patients and their families as the first and only therapy to help protect against chemotherapy-induced myelosuppression.”
FDA Approves G1 Therapeutics’ COSELA™ (trilaciclib): The First and Only Myeloprotection Therapy to Decrease the Incidence of Chemotherapy-Induced Myelosuppression
February 12, 2021 19:41 ET | Source: G1 Therapeutics G1 Therapeutics
- COSELA is the only FDA-approved therapy that helps proactively deliver multilineage myeloprotection to patients with
extensive-stage small cell lung cancer being treated with chemotherapy -
- Myeloprotective efficacy of COSELA resulted in reductions in the incidence and duration of severe neutropenia, and impacted anemia and the need for rescue interventions such as growth factors and red blood cell transfusions -
- G1 will host conference call Tuesday, February 16, 2021 at 8:00 a.m. ET -
RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2021 (GLOBE NEWSWIRE) G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved COSELA
Stem cells in bag in Gamida Cell’s Jerusalem lab, July 2017 (Shoshanna Solomon/TimesofIsrael)
All of these “are meaningful results and represent potentially important advancements in care when considering the patient experience following transplant,” said Mitchell Horwitz, principal investigator and professor of medicine at the Duke Cancer Institute, in a statement released by the Jerusalem-based firm.
The data was from the international, multi-center, randomized Phase 3 study of the drug, designed to evaluate the safety and efficacy of omidubicel in patients with high-risk hematologic malignancies undergoing a bone marrow transplant compared with a group of patients who received a standard umbilical cord blood transplant.
Including palliative care early in the course of cancer therapy for patients with advanced acute myeloid leukemia results in substantial improvements in quality of life, mood, and end-of-life care, according to a new study.
The findings demonstrate the benefits of early integration of palliative care for symptoms and stress into oncology care for patients with high-risk acute myeloid leukemia (AML), a highly aggressive cancer of the blood and bone marrow.
“This is the first multi-site randomized trial of an integrated palliative care intervention in patients with any blood cancer,” says Thomas W. LeBlanc, a medical oncologist and palliative care physician at Duke Cancer Institute and co-lead author of the study in