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2022-03-16T10:13:40.000Z

Orphan drug designation granted to DT2216 for the treatment of T-cell lymphoma

Mar 16, 2022
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Learning objective: After reading this article, learners will be able to cite a new clinical development in lymphoma/CLL

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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.

  1. 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.
  2. 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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