Concerning FDA approval of trilaciclib (Cosela) in extensive-stage small-cell lung cancer

Trilaciclib is a recently approved cyclin-dependent kinase 4/6 inhibitor that is designed to decrease the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-stage small-cell lung cancer receiving chemotherapy. Currently, this first-in-class therapy raises two open issues: its bio-plausibility and paucity of evidence demonstrating a lasting impact on clinical endpoints. Based on the existing phase 2 data, trilaciclib appears to be a therapy that can make a positive impact by preventing myelosuppression, but empirical validation with larger phase III trials should be conducted to confirm these benefits. The purpose of this article is to facilitate discussion about the role of trilaciclib in clinical practice and the need for additional trials.