China’s NMPA has approved tunlametinib for the treatment of patients with NRAS-mutated advanced melanoma after prior anti–PD-1/PD-L1 therapy.
China’s National Medical Products Administration (NMPA) has approved tunlametinib (HL-085) for the treatment of patients with advanced melanoma harboring NRAS mutations who were previously treated with anti–PD-1/PD-L1 therapy.
Publications
First China, then the world: new MEK blocker wins melanoma nod
Shanghai-based KeChow Pharma has secured approval in its home country for tunlametinib, a MEK blocker which was discovered and developed by the firm in-house.
AI-Powered Detection System for Skin Cancers Receives FDA Approval
The first real-time, non-invasive skin cancer evaluation system, which can detect basal cell carcinoma, melanoma, and squamous cell carcinoma, has been granted clearance by the FDA, according to a press release from DermaSensor Inc.
FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma
On February 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, for adult patients with unresectable or metastatic melanoma who were previously treated with a PD-1 blocking antibody, or, if they have BRAF V600 mutation–positive disease, a BRAF inhibitor with or without a MEK inhibitor.
C-144-01 Trial