Ascentage Pharma’s Alrizomadlin Gets RPD Designation for Neuroblastoma

The FDA has granted China-based Ascentage Pharma a Rare Pediatric Disease (RPD) designation for alrizomadlin (APG-115), its selective, small-molecule inhibitor of the MDM2 protein, for the treatment of neuroblastoma.

The orally administered drug has now received six Orphan Drug designations and two RPD designations from the FDA, including for the treatment of patients with relapsed/refractory unresectable or metastatic melanoma.

Ascentage said it will now launch a clinical trial to test alrizomadrlin in patients with neuroblastoma.