FDA Grants Orphan Drug Designation to Alrizomadlin for Stage IIB-IV Melanoma

Source: OncLive, July 2021

The FDA has granted an orphan drug designation to alrizomadlin (APG-115) as a potential therapeutic option for patients with stage IIB-IV melanoma, according to an announcement from Ascentage Pharma, the drug developer.1

Alrizomadlin is an oral selective, small molecule, MDM2-p53 inhibitor. The agent was designed to block MDM2-p53 protein–protein interaction and to restore p53-mediated apoptosis in tumor cells with wild-type TP53 or MDM2 amplification.2

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