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


The FDA has granted Orphan Drug Designation (ODD) to alrizomadlin (APG-115, Ascentage Pharma) for the treatment of stage IIB-IV melanoma.

The FDA has granted Orphan Drug Designation (ODD) to alrizomadlin (APG-115, Ascentage Pharma) for the treatment of stage IIB-IV melanoma. This marks the fifth ODD granted to the drug, in addition to designations for the treatment of gastric cancer, acute myeloid leukemia, soft tissue sarcoma, and retinoblastoma, according to a press release.

Significant progress has been achieved in recent years in the clinical treatment of patients with metastatic or unresectable melanoma, with therapies such as mitogen-activated protein kinase inhibitors and immunotherapies to help improve patients’ overall survival and quality of life. Although immunotherapies have been studied and used broadly in treatment, a significant number of patients will eventually develop resistance to immune checkpoint inhibitors (ICIs), which does not have an approved treatment for patients with ICI-resistant melanoma.

Alrizomadlin is an orally administered, selective MDM2-p53 inhibitor that, when combined with a PD-1 blockade, enhances antitumor activities by triggering adaptive antitumor immunity. A cohort of patients with PD-1/PD-L1 inhibitor-resistant melanoma treated with alrizomadlin plus pembrolizumab had 1 patient achieve a complete response, an objective response rate of 24.1%, and a disease control rate of 55.2%.

These findings showed the interaction between alrizomadlin and immune-oncologic drugs, and a potential regimen that could provide hope to patients with ICI-resistant melanoma, according to the press release.

"At present, there is a large unmet medical need for the treatment of melanoma. Therefore, this ODD for alrizomadlin bears tremendous significance," said Yifan Zhai, MD, chief medical officer of Ascentage Pharma, in a press release. “The FDA's supporting policy for orphan drug development will help us to further accelerate the clinical development of alrizomadlin and other drug candidates in our pipeline and hopefully we can bring these potential novel therapies to patients as soon as possible."


Ascentage Pharma's MDM2-p53 Inhibitor APG-115 (Alrizomadlin) Granted an Orphan Drug Designation by the FDA for the Treatment of Stage IIB-IV Melanoma, Marking the Twelfth Obtained by the Company. July 21,2021. Accessed July 22, 2021. https://www.prnewswire.com/news-releases/ascentage-pharmas-mdm2-p53-inhibitor-apg-115-alrizomadlin-granted-an-orphan-drug-designation-by-the-fda-for-the-treatment-of-stage-iib-iv-melanoma-marking-the-twelfth-obtained-by-the-company-301338428.html

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