FX.co ★ Innovent Gets Fast Track Designation From FDA For IBI363 As Monotherapy For Advanced Melanoma

Innovent Biologics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2a Bispecific Antibody Fusion Protein for treating patients with unresectable locally advanced or metastatic melanoma (excluding choroidal melanoma) who have experienced progression following at least one systemic therapy, including a PD-1/L1 inhibitor.

The company highlighted that phase 1/2 clinical trials are currently being conducted in China, the U.S., and Australia to evaluate the efficacy and safety of IBI363 across various advanced malignant tumors.

Fast Track Designation (FTD) is a streamlined review process that aims to facilitate the clinical development of drugs that might address serious conditions and unmet medical needs. Drugs granted FTD status are afforded more frequent communication opportunities with the FDA throughout their development and review stages, which helps expedite their clinical development and approval process.