US FDA approves trilaciclib for chemo-induced bone marrow damage

US FDA  approves trilaciclib for chemo-induced bone marrow damage

The US FDA has approved trilaciclib (Cosela) for reducing the frequency of chemotherapy-related bone marrow suppression in adults with extensive-stage small cell lung cancer, announced the G1 Therapeutics.

Trilaciclib is a small molecule, a competitive inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), with potential antineoplastic and chemoprotective activities.

The drug is administered intravenously. Trilaciclib acts by binding to and inhibiting the activity of CDK4/6, thereby blocking the phosphorylation of the retinoblastoma protein (Rb) which leads to cell cycle arrest, causing apoptosis and inhibiting the proliferation of CDK4/6-overexpressing tumour cells.

Trilaciclib was evaluated in three randomized, double-blind, placebo-controlled studies in patients with extensive-stage small-cell lung cancer, all of which showed patients assigned the drug had decreased risk for severe neutropenia compared with patients assigned placebo, stated the FDA agency.

“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,” Albert Deisseroth, MD, PhD, supervisory medical officer in the FDA’s Division of Non-Malignant Hematology, said in the statement.