The China National Medical Products Administration (NMPA) has approved Innovent Biologics’ new drug application (NDA) for selpercatinib to treat lung and thyroid cancers.
Selpercatinib obtained the approval to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion.
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It is also intended for advanced or metastatic RET mutation medullary thyroid cancer (MTC) in paediatric and adult patients aged 12 years and above who require systemic therapy.
The drug is also indicated for the treatment of advanced or metastatic RET gene fusion thyroid cancer (TC) patients of the same age group who require systemic therapy and are radioactive iodine-refractory.
Last November, the Center for Drug Evaluation (CDE) of China NMPA accepted the NDA for selpercatinib and granted priority review to accelerate the review process for the therapy.
The acceptance of NDA was based on data obtained from the international LIBRETTO-001 study and the Chinese patient population in an open-label, multicentre Phase II LIBRETTO-321 study.
Innovent president Dr Yongjun Liu said: “Globally, selpercatinib is the first RET inhibitor approved and we are pleased to see its strong and durable response in line with good tolerability in clinical studies.
“This approval marks another milestone in mainland China for targeted therapies and will bring a new treatment option with high quality to RET fusion-positive cancer patients in China.
“For Innovent, the addition of a high-value commercialised product in our TKI BU will further enhance the synergistic value in the pipeline portfolio as well as our franchise in certain cancer types.”
The company and Eli Lilly and Company expanded their strategic partnership in oncology in March.
