FDA Fast Tracks Naporafenib for Unresectable, Metastatic Melanoma
Source: Applied Clinical Trials Online, December 2023
The Phase III SEACRAFT-2 trial will analyze the clinical efficacy of naporafenib compared with physician’s choice of single-agent dacarbazine, temozolomide, or trametinib among patients with NRAS-mutated metastatic melanoma who received prior treatment with an immunotherapy.
Erasca’s naporafenib (ERAS-254) has been granted FDA Fast Track Designation for the treatment of adults with unresectable or metastatic melanoma with an NRAS mutation who progressed on or who are intolerant to a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1)–based regimen. Naporafenib, a selective pan-RAF inhibitor, was found to produce early activity in a multicenter, open-label, Phase Ib trial (NCT02974725) for metastatic melanoma.
“We are now rapidly advancing clinical development of naporafenib in combination with trametinib in the post-[immunotherapy] setting in patients with NRAS-mutant melanoma with initiation of our pivotal phase 3 SEACRAFT-2 trial expected in the first half of 2024,” said Jonathan E. Lim, MD, chairman, chief executive officer, and co-founder of Erasca, Inc., in a press release.1 “Receiving fast track designation further strengthens our ability to work closely with the FDA toward our goal of bringing this new therapy for difficult-to-treat melanoma to patients as soon as possible.”