Novel Bispecific Antibody Fusion Protein Earns FDA Fast Track in Melanoma
Source: Targeted Oncology, September 2024
IBI363 has earned fast track designation from the FDA for the treatment of previously treated unresectable advanced melanoma.
- The FDA has granted a fast track designation to IBI363 for the treatment of unresectable locally advanced or metastatic melanoma that has progressed following at least 1 line of systemic therapy, including a PD-(L)1 inhibitor.
- IBI363 is an investigational PD-1/IL-2? bispecific antibody fusion protein.
- Phase 1/2 trials are evaluating the agent’s safety in advanced malignant tumors.
IBI363, a PD-1/IL-2? bispecific antibody fusion protein, has been granted fast track designation from the FDA in patients with unresectable locally advanced or metastatic melanoma who have progressed following at least 1 line of systemic therapy, including a PD-(L)1 inhibitor.