RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another indication approval filing for its drug candidate disitamab vedotin (RC48). The antibody-drug conjugate (ADC) has been granted priority review status. This new indication is for the treatment of HER2 positive advanced breast cancer patients with liver metastasis, who have previously been treated with trastuzumab or its biosimilar and taxanes.
The filing is supported by the results of an ongoing, open, parallel controlled, multi-center Phase III study, which aims to assess the efficacy and safety of disitamab vedotin compared to lapatinib plus capecitabine in HER2 positive advanced breast cancer patients.
Disitamab vedotin made history as the first home-grown ADC from China, obtaining conditional market approval in June 2021 for the third-line treatment of HER2-positive gastric cancer (GC). The NMPA further expanded the molecule’s indications, granting a second approval to treat urothelial cancer (UC) on December 31, 2021. The drug is already recognized as a Category B product on the National Reimbursement Drug List (NRDL).- Flcube.com
