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Published on: August 10, 2017
Romidepsin: a novel histone deacetylase inhibitor for cancer
Erin M Bertino1, Gregory A Otterson
1The Ohio State University, Comprehensive Cancer Center, Department of Internal Medicine, Columbus, USA.
Introduction:
Romidepsin is a novel histone deacetylase (HDAC) inhibitor, with a recent approval for treatment of cutaneous T-cell lymphoma (CTCL). HDAC inhibitors represent a novel approach to anti-tumor therapy. In contrast to traditional cytotoxic chemotherapy, HDAC inhibitors target underlying epigenetic changes leading to malignant transformation. Further study of romidepsin and similar agents in solid and hematologic malignancies is ongoing.
Areas Covered:
This review discusses the development of romidepsin, its mechanism of action, pivotal clinical trials, drug toxicity and its recent approval for CTCL treatment. Key clinical trials covered include Phase I/II testing of romidepsin in solid and hematologic malignancies. In addition, the Phase II trial in CTCL leading to FDA approval of romidepsin is reviewed in detail. Literature search was performed using PubMed; keywords and concepts used included romidepsin, T-cell lymphoma and HDAC inhibitors.
Expert Opinion:
Romidepsin is a potent HDAC inhibitor with demonstrable activity in T-cell lymphoma. In contrast to vorinostat, romidepsin is approved as second-line therapy. Current approval only includes CTCL; promising results have been demonstrated in Phase II testing of peripheral T-cell lymphoma subtypes. Future directions include expanded indications in T-cell lymphomas as well as novel combinations with other HDAC inhibitors and other therapeutic agents.
Insights
Romidepsin, a novel histone deacetylase (HDAC) inhibitor, is approved for cutaneous T-cell lymphoma (CTCL). This epigenetic therapy shows promise in T-cell lymphomas, with ongoing research for broader applications.
Area of Science:
- Oncology
- Pharmacology
- Epigenetics
Background:
- Romidepsin is a novel histone deacetylase (HDAC) inhibitor.
- HDAC inhibitors offer a new approach to anti-tumor therapy by targeting epigenetic changes.
- Romidepsin has recently been approved for treating cutaneous T-cell lymphoma (CTCL).
Purpose of the Study:
- To review the development and mechanism of action of romidepsin.
- To discuss pivotal clinical trials, including Phase I/II studies in various malignancies and the Phase II trial in CTCL.
- To detail drug toxicity and the FDA approval process for romidepsin in CTCL.
Main Methods:
- Literature search using PubMed with keywords: romidepsin, T-cell lymphoma, and HDAC inhibitors.
- Review of key clinical trials, including Phase I/II testing and the Phase II CTCL trial.
- Analysis of romidepsin's mechanism, toxicity, and regulatory approval.
Main Results:
- Romidepsin demonstrates potent activity as an HDAC inhibitor in T-cell lymphomas.
- The drug is approved as a second-line therapy, specifically for CTCL.
- Phase II trials show promising results in peripheral T-cell lymphoma subtypes.
Conclusions:
- Romidepsin is an effective HDAC inhibitor for T-cell lymphoma, particularly CTCL.
- While approved for CTCL, its potential extends to other T-cell lymphomas.
- Future research will explore expanded indications and combinations with other therapies.
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