9 October 2022 - Innovent Biologics is pleased to see that the NMPA of China has approved the new drug application for selpercatinib for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with a rearranged during transfection (RET) gene fusion, adult and paediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation who require systemic therapy, and adult and paediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Selpercatinib was evaluated in the Phase I/II LIBRETTO-001 study, the largest clinical trial ever reported in patients with RET driven cancers.