Regulatory

Tunlametinib Wins Approval in China for NRAS+ Advanced Melanoma After PD-1/PD-L1 Therapy

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.

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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

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