22 September 2021 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor alrizomadlin (APG-115) has been granted a fast track designation by the US FDA for the treatment of patients with unresectable or metastatic melanoma, relapsed/refractory to prior immuno-oncologic agent treatments.
Previously, alrizomadlin was already granted five orphan drug designations by the US FDA, one of which was for the treatment of stage IIB-IV melanoma.