Istodax
Evidence Grade A — Regulatory approved. 806 published studies. 99 registered clinical trials.
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Romidepsin (sold as Istodax) is an intravenous cancer treatment for rare forms of T-cell lymphoma — cancers of a specific type of white blood cell. Derived from a soil bacterium, it enters cancer cells in disguise and then switches on genes that the cancer had silenced to avoid self-destruction. It is one of very few effective treatments available for these rare lymphomas.
806 published studies: 628 human, 34 animal, 211 in-vitro, 164 reviews
Romidepsin is marketed as Istodax (approved November 2009 for cutaneous T-cell lymphoma; June 2011 for peripheral T-cell lymphoma). Administered as an intravenous infusion over 4 hours on a cyclical schedule.
In T-cell lymphoma trials, romidepsin achieved response rates of 25–34%, with some durable complete responses lasting over two years. A Phase III trial (Ro-CHOP) adding romidepsin to standard chemotherapy for peripheral T-cell lymphoma did not meet its primary endpoint, which has narrowed its role primarily to relapsed disease. The main side effects include nausea, fatigue, low blood counts, and ECG changes. Romidepsin occupies a niche in a disease area with very few effective treatments.
Cancer cells often survive by chemically silencing tumour suppressor genes — the genes that would normally tell a damaged cell to stop dividing or self-destruct. They do this by keeping DNA tightly wound around proteins called histones. Romidepsin enters the cell in a disguised, inactive form. Once inside, the cell's own chemistry activates it, releasing zinc-binding arms that block the enzymes (HDACs) responsible for keeping DNA wound tight. This loosens the DNA, reactivating the silenced tumour suppressor genes and triggering cancer cell death.
In T-cell lymphoma trials, romidepsin achieved response rates of 25–34%, with some patients experiencing durable complete responses lasting over two years. For a cancer type with very few effective treatments, these response rates are clinically meaningful — though the majority of patients did not respond. A Phase III trial (Ro-CHOP) testing romidepsin as part of frontline combination chemotherapy did not meet its primary endpoint, which has narrowed its role primarily to relapsed or refractory disease. Side effects include nausea, fatigue, low blood counts, and ECG changes requiring cardiac monitoring. The drug's mechanism — reactivating silenced tumour-suppressor genes by loosening how DNA is packaged — represents an important concept in cancer biology that continues to be explored in combination with newer immunotherapy approaches.
A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of Depsipeptide (FK228) in Patients That Have Completed a Prior Clinical Study With Depsipeptide.
Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents
Evaluation of the Safety and the Tolerability of a Combination of Two HIV Inducers in Patients With Undetectable Viral Load
Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma
Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas
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