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Orphan drug designation granted to DT2216 for the treatment of T-cell lymphoma
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On March 14, 2022, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to DT2216, a compound based on antiapoptotic protein targeted degradation technology, for the treatment of T-cell lymphoma1.
DT2216 is a first-generation compound designed to induce degradation of BCL-XL, an anti-apoptotic protein involved in malignant cell survival.1,2. This agent is currently being evaluated in a phase I clinical trial involving patients with confirmed advanced or metastatic solid tumors and hematologic malignancies that are unresponsive to currently approved treatments1.
It is hoped that DT2216 can help to address a critical unmet need for patients diagnosed with this rare form of cancer.
- PR Newswire. Dialectic Therapeutics announces DT2216 has received orphan drug designation from the FDA for the treatment of T-cell lymphoma. https://www.prnewswire.com/news-releases/dialectic-therapeutics-announces-dt2216-has-received-orphan-drug-designation-from-the-fda-for-the-treatment-of-t-cell-lymphoma-301501813.html. Published Mar 14, 2022. Accessed Mar 15, 2022.
- Khan S, Zhang X, Lv D, et al, A selective BCL-XL PROTAC degrader achieves safe and potent antitumor activity. Nat Med. 2019;25(12):1938-1947. DOI 1038/s41591-019-0668-z
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