Posted by Michael Wonder on 05 Sep 2024
Innovent receives fast track designation from the US FDA for IBI363 (PD-1/IL-2α bispecific antibody fusion protein) as monotherapy for advanced melanoma
4 September 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its PD-1/IL-2α bispecific antibody fusion protein (R&D code: IBI363) for the treatment of unresectable locally advanced or metastatic melanoma (except choroidal melanoma) in patients who have progressed after at least one line of systemic therapy, which must include a PD-1/L1 inhibitor.
Phase 1/2 clinical trials are currently underway in China, the US and Australia to assess IBI363's efficacy and safety in various advanced malignant tumours.
