Innovent receives US FDA fast track designation for IBI363 as monotherapy for advanced melanoma
Innovent Biologics' PD-1/IL-2a-bias Bispecific Antibody Fusion Protein (IBI363) received Fast Track Designation from the FDA for treating melanoma. Phase 1/2 trials in China, the US, and Australia show promising efficacy, with 29.7% ORR and 73.0% DCR in melanoma patients previously treated with immunotherapy. IBI363 aims to address unmet needs for immunotherapy-resistant melanoma.
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IBI363 received FDA fast track designation for melanoma; Boruzu, a ready-to-use bortezomib, was approved for multiple myeloma and mantle cell lymphoma; combining lenvatinib with pembrolizumab shows efficacy in non-clear renal cell carcinoma; cost-effectiveness of TKIs in chronic myeloid leukemia was discussed; immunotherapies for T-cell lymphomas were reviewed.
FDA fast track designation granted to IBI363, a PD-1/IL-2α bispecific antibody fusion protein, for treating advanced melanoma after immunotherapy failure. Phase 1/2 trials show encouraging efficacy and safety, with a 29.7% objective response rate and 73.0% disease control rate in previously treated patients.
Innovent Biologics' PD-1/IL-2a-bias Bispecific Antibody Fusion Protein (IBI363) received Fast Track Designation from the FDA for treating melanoma. Phase 1/2 trials in China, the US, and Australia show promising efficacy, with 29.7% ORR and 73.0% DCR in melanoma patients previously treated with immunotherapy. IBI363 aims to address unmet needs for immunotherapy-resistant melanoma.