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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR ISTODAX


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All Clinical Trials for Istodax

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00053963 ↗ FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia Completed National Cancer Institute (NCI) Phase 1 2002-09-01 This phase I trial is studying the side effects and best dose of FR901228 in treating children with refractory or recurrent solid tumors or leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
NCT00062075 ↗ Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Completed National Cancer Institute (NCI) Phase 2 2003-05-01 This phase II trial is studying how well romidepsin works in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.
NCT00079443 ↗ FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma Terminated National Cancer Institute (NCI) Phase 2 2004-01-01 This phase I/II trial is studying the best dose of FR901228 when given together with rituximab and fludarabine and to see how well FR901228 works alone in treating patients with relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as FR901228 and fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Rituximab may increase the effectiveness of chemotherapy drugs by making cancer cells more sensitive to the drugs.
NCT00084461 ↗ Romidepsin in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors Terminated National Cancer Institute (NCI) Phase 2 2004-03-01 Phase II trial to study the effectiveness of romidepsin in treating patients who have locally advanced or metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.
NCT00084682 ↗ Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Completed National Cancer Institute (NCI) Phase 2 2005-06-01 This phase II trial is studying how well FR901228 works in treating patients with unresectable recurrent or metastatic squamous cell carcinoma (cancer) of the head and neck. Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or die.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Istodax

Condition Name

Condition Name for Istodax
Intervention Trials
Lymphoma 5
Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma 5
Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma 4
Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma 4
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Condition MeSH

Condition MeSH for Istodax
Intervention Trials
Lymphoma 27
Lymphoma, T-Cell 21
Lymphoma, T-Cell, Peripheral 16
Lymphoma, Non-Hodgkin 13
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Clinical Trial Locations for Istodax

Trials by Country

Trials by Country for Istodax
Location Trials
United States 105
United Kingdom 4
France 3
Denmark 2
Australia 2
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Trials by US State

Trials by US State for Istodax
Location Trials
New York 11
California 10
Texas 8
Ohio 8
Illinois 8
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Clinical Trial Progress for Istodax

Clinical Trial Phase

Clinical Trial Phase for Istodax
Clinical Trial Phase Trials
Phase 3 2
Phase 2 16
Phase 1/Phase 2 11
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Clinical Trial Status

Clinical Trial Status for Istodax
Clinical Trial Phase Trials
Completed 18
Terminated 11
Recruiting 7
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Clinical Trial Sponsors for Istodax

Sponsor Name

Sponsor Name for Istodax
Sponsor Trials
National Cancer Institute (NCI) 22
Celgene Corporation 10
Celgene 8
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Sponsor Type

Sponsor Type for Istodax
Sponsor Trials
Other 50
Industry 26
NIH 23
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Clinical Trials Update, Market Analysis, and Projections for Istodax

Introduction

Istodax, also known as romidepsin, is a histone deacetylase (HDAC) inhibitor developed by Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb. Initially approved for the treatment of peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL), the drug has recently faced significant changes in its clinical and market status.

Clinical Trials Overview

Initial Approval and Early Trials

Istodax was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in 2011 for the treatment of PTCL in adult patients who had received at least one prior therapy. This approval was based on positive results from two single-arm clinical trials that showed a good overall response rate[2][4].

Confirmatory Phase III Trial

However, the confirmatory Phase III trial (NCT01796002) aimed to validate these findings in newly diagnosed PTCL patients did not meet its primary efficacy endpoint. The trial compared the efficacy of romidepsin plus CHOP (Ro-CHOP) versus CHOP alone. Despite a slight improvement in progression-free survival (median 12 months for Ro-CHOP vs. 10.2 months for CHOP), the difference was not statistically significant[2][4][5].

Market Impact and Withdrawal

Withdrawal from PTCL Market

Due to the disappointing results of the confirmatory trial, Bristol Myers Squibb decided to withdraw Istodax's indication for the treatment of PTCL. This decision aligns with the FDA's increased scrutiny of drugs that have received accelerated approvals but failed to demonstrate sufficient clinical benefit in confirmatory trials[2][4][5].

Continued Use in CTCL

Despite the withdrawal for PTCL, Istodax remains an approved and important treatment option for patients with cutaneous T-cell lymphoma (CTCL) who have received at least one systemic therapy. This indicates that the drug still has a viable market segment[1][4][5].

Safety Profile

The safety profile of Istodax has been a significant concern. Clinical trials have identified serious treatment-related adverse events, including pancytopenia, QT interval prolongation, fatal infections, tumor lysis syndrome, and potential fetal harm. Common adverse events include functional gastrointestinal disorders, hematological disorders, asthenic conditions, infections, pyrexia, anorexia, and dysgeusia[3].

Market Analysis

Sales and Revenue

Before the withdrawal, Istodax sales had been declining. In 2018, Celgene reported a 17% year-over-year decline in Istodax sales to $63 million. The removal of the PTCL indication is not expected to significantly impact Bristol Myers Squibb's topline revenue[2].

Competitive Landscape

The PTCL treatment landscape has evolved since Istodax's introduction. For example, Seagen's antibody-drug conjugate Adcetris, used in combination with chemotherapy, became the first FDA-approved drug for newly diagnosed PTCL in 2018. This competition, along with the failure of Istodax in confirmatory trials, has further diminished its market position in PTCL[2].

Projections and Future Outlook

Ongoing Use in CTCL

Istodax will continue to be a treatment option for CTCL patients, maintaining its market presence in this niche. However, the drug's overall market share and influence are likely to remain limited due to its restricted indications and the availability of alternative treatments[1][4][5].

Research and Development

Bristol Myers Squibb has emphasized its commitment to delivering better outcomes for patients through ongoing research and development in blood cancer. While Istodax may not be a key player in PTCL treatment, the company's broader portfolio and research efforts are expected to drive innovation in the oncology sector[1][4].

Regulatory Environment

The FDA's increased scrutiny of accelerated approvals that have not demonstrated sufficient clinical benefit in confirmatory trials has significant implications for the pharmaceutical industry. This trend is likely to continue, with more drugs facing similar evaluations and potential withdrawals if they fail to meet efficacy endpoints[2].

Patient Impact

Patients currently using Istodax for PTCL are advised to consult their healthcare providers to determine the next course of treatment. For those with CTCL, the continued availability of Istodax provides a stable treatment option, although patients and healthcare providers must remain vigilant about the drug's safety profile[1][4][5].

Key Takeaways

  • Istodax (romidepsin) has been withdrawn from the market for the treatment of peripheral T-cell lymphoma (PTCL) due to a lack of clinical benefit in confirmatory trials.
  • The drug remains approved for the treatment of cutaneous T-cell lymphoma (CTCL).
  • The safety profile of Istodax includes serious adverse events such as pancytopenia, QT interval prolongation, and fatal infections.
  • The PTCL treatment landscape has evolved with new drugs like Adcetris, reducing Istodax's market significance.
  • Bristol Myers Squibb continues to focus on delivering better outcomes for patients through ongoing research and development.

FAQs

What is Istodax, and how does it work?

Istodax, or romidepsin, is a histone deacetylase (HDAC) inhibitor that works by causing an accumulation of acetylated histones, leading to cell arrest and apoptosis in some cancer cell lines.

Why was Istodax withdrawn from the PTCL market?

Istodax was withdrawn from the PTCL market because it failed to meet its primary efficacy endpoint in a confirmatory Phase III trial, showing no statistically significant benefit over the standard CHOP chemotherapy regimen.

Is Istodax still available for any other indications?

Yes, Istodax remains an approved treatment for patients with cutaneous T-cell lymphoma (CTCL) who have received at least one systemic therapy.

What are the common adverse events associated with Istodax?

Common adverse events include functional gastrointestinal disorders, hematological disorders, asthenic conditions, infections, pyrexia, anorexia, and dysgeusia. Serious adverse events include pancytopenia, QT interval prolongation, fatal infections, and tumor lysis syndrome.

How does the withdrawal of Istodax affect Bristol Myers Squibb's revenue?

The withdrawal of Istodax for PTCL is not expected to significantly impact Bristol Myers Squibb's topline revenue, as the drug's sales had already been declining.

What other treatment options are available for PTCL patients?

Other treatment options for PTCL include Adcetris, an antibody-drug conjugate approved for newly diagnosed PTCL patients, and other chemotherapy regimens.

Sources

  1. BioSpace: Bristol Myers Squibb Pulls Istodax in Lymphoma After Trial Fails to Show Efficacy.
  2. FiercePharma: Bristol Myers pulls an Istodax lymphoma use 10 years after FDA accelerated approval.
  3. Health Canada: Summary Basis of Decision for Istodax.
  4. Cancer Network: Bristol Myers Squibb Withdraws Romidepsin R/R Peripheral T-Cell Lymphoma Indication for Lack of Clinical Benefit.
  5. Targeted Oncology: BMS Pulls Romidepsin for Peripheral T-cell Lymphoma from US Market.

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