Jiangsu Simcere Pharmaceutical Co., Ltd’s trilaciclib has received marketing approval from the National Medical Products Administration (NMPA) for reducing chemotherapy-induced myelosuppression (CIM) in adult patients with extensive-stage small cell lung cancer (ES-SCLC). The drug, licensed from US biotech G1 Therapeutics, was approved under a prioritized review process.
Drug Profile
Trilaciclib, a first-in-class CDK4/6 inhibitor, is the world’s first comprehensive myeloprotective therapy against chemotherapy damage. The drug was approved in the US in February 2021 as Cosela, with a breakthrough therapy designation (BTD). It has demonstrated consistent pharmacokinetic (PK) characteristics and clinical benefits in Chinese and global trials, with no new safety signals.
Approval Details
The NMPA’s approval covers trilaciclib’s use prior to platinum/etoposide regimens in ES-SCLC patients. The drug is also under investigation for colorectal cancer, triple-negative breast cancer, and other indications.-Fineline Info & Tech
