China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that the supplementary New Drug Application (sNDA) for its Category 1 anti-cancer drug donafenib in locally advanced / metastatic radioiodine-refractory differentiated thyroid cancer (RAIR-DTC) has been approved by the National Medical Products Administration (NMPA). This is the second indication approval for the drug, following its approval for unresectable hepatocellular carcinoma (HCC) without prior systemic therapy in June last year.
Drug Details
Donafenib is an orally available multikinase inhibitor that targets Raf kinase and various receptor tyrosine kinases (RTKs). The approval is based on the results of a multi-center, randomized, double-blind, placebo-controlled Phase II study. The study showed that compared with the placebo, donafenib significantly reduced the risk of disease progression, significantly prolonged disease progression-free survival, and produced a better objective response rate.
Market Recognition
The drug was included in the National Reimbursement Drug List (NRDL) in 2021 and is recommended in the 2022 edition of Chinese guidelines for the diagnosis and treatment of primary liver cancer.
Clinical Trials
Fineline Info & Tech database shows that donafenib is the subject of 83 clinical studies in China, including 8 Phase III studies. These studies cover advanced HCC, DTC, advanced colorectal cancer (CRC), and more. Although the trial in CRC was prematurely terminated, the drug is also being assessed in pancreatic cancer, bile duct cancer, nasopharyngeal cancer, esophageal cancer, cervical cancer, acute myeloid leukemia, and others.-Fineline Info & Tech
