Cosela Approved for Protection Against Myelosuppression From SCLC Treatment
The cyclin-dependent kinase 4/6 inhibitor trilaciclib (Cosela) is the first in its class to receive FDA approval as a protective agent against bone marrow loss from treatment for small cell lung cancer (SCLC).
The FDA approved trilaciclib (Cosela; G1 Therapeutics) to be used as a protective agent against bone marrow loss among adults before
Bone marrow loss and myelosuppression are well-documented adverse effects (AEs) of chemotherapy, leaving the immune system without some of its most potent fighters: red blood cells, which contain hemoglobin; white blood cells, which help to fight infection; and platelets, which assist in clotting. These losses, in turn, can cause fatigue and increase risks of infection, bleeding, anemia, and thrombocytopenia.
Previous treatments that address bone marrow injury have only attempted to remedy it after the fact. “To date, approaches have included the use of growth factor agents to accelerate blood cell recovery after the bone marrow injury has occurred, along with antibiotics and transfusions as needed,”
G1 Therapeutics’ application was backed by data from 3 double-blind, placebo-controlled studies of 245 patients randomized to intravenous (IV) trilaciclib or placebo, with dual primary outcomes of severe neutropenia and its length during the first chemotherapy cycle. The effectiveness of trilaciclib plus carboplatin/etoposide (with or without atezolizumab) or topotecan was evaluated in these trials. Severe neutropenia was a less likely outcome, and lasted for a shorter time among those for whom it did occur, following treatment with trilaciclib. These findings were deemed clinically meaningful and statistically significant.
Most common AEs (≥10%) of the treatment are fatigue, headache, high aspartate aminotransferase levels, pneumonia, and low calcium, potassium, and phosphate levels. Injection-site reactions, acute drug hypersensitivity, interstitial
Serious AEs that occurred (>3%) were
“For patients with extensive-stage small cell lung cancer, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time and according to plan,” said Albert Deisseroth, MD, PhD, supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research,
Cosela received a
The treatment is administered as a 30-minute IV infusion within 4 hours of the start of chemotherapy.
Reference
FDA approves G1 Therapeutics’ Cosela (trilaciclib): the first and only myeloprotection therapy to decrease the incidence of chemotherapy-induced myelosuppression. News release. G1 Therapeutics. February 12, 2021. Accessed February 17, 2021. http://investor.g1therapeutics.com/news-releases/news-release-details/fda-approves-g1-therapeutics-coselatm-trilaciclib-first-and-only
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