FDA Events for Delcath Systems (DCTH)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Delcath Systems (DCTH).
Over the past two years, Delcath Systems has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
HEPZATO. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
HEPZATO KIT - FDA Regulatory Timeline and Events
HEPZATO KIT is a drug developed by Delcath Systems for the following indication: For the treatment of metastatic uveal melanoma (mUM).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HEPZATO KIT
- Announced Date:
- April 28, 2025
- Indication:
- For the treatment of metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC).
AI Summary
Delcath Systems, Inc. announced that the U.S. Food and Drug Administration has completed its 30‐day review of the Company’s Investigational New Drug (IND) application for a Phase 2 clinical trial. This trial will evaluate HEPZATO in combination with standard of care (SOC) versus SOC alone in patients with liver-dominant, HER2-negative metastatic breast cancer whose previous treatments have failed.
With the FDA review now complete, Delcath is cleared to begin enrolling patients in the United States. Approximately 90 patients will be enrolled at more than 20 sites across the US and Europe, with recruitment expected to start in the fourth quarter of 2025. The primary aim of the study is to measure hepatic progression-free survival, offering critical insights into the safety and potential benefits of delivering high-dose chemotherapy directly to the liver.
Read Announcement- Drug:
- HEPZATO KIT
- Announced Date:
- December 2, 2024
- Indication:
- For the treatment of metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for liver-dominant metastatic colorectal cancer (mCRC). With the FDA's review complete, Delcath is now authorized to initiate patient enrollment.
AI Summary
Delcath Systems, Inc. announced that the U.S. Food and Drug Administration (FDA) has finished its 30-day review of the company’s Investigational New Drug (IND) application. This review is for a Phase 2 clinical trial that will evaluate HEPZATO™ in combination with standard care for patients with liver-dominant metastatic colorectal cancer (mCRC). With the FDA’s evaluation complete, Delcath has received authorization to begin enrolling patients in the trial. The study will compare the safety and efficacy of HEPZATO combined with a regimen of trifluridine-tipiracil and bevacizumab against the standard treatment using trifluridine-tipiracil and bevacizumab alone. This milestone is an important step for Delcath as it moves forward in testing a new treatment option aimed at offering hope to patients with liver-dominant mCRC.
Read Announcement - Drug:
- HEPZATO KIT
- Announced Date:
- September 16, 2024
- Indication:
- For the treatment of metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc announced the presentation of new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) in patients with metastatic uveal melanoma (mUM).
AI Summary
Delcath Systems, Inc recently presented new subgroup analysis data from the FOCUS Phase 3 trial of its HEPZATO KIT™, a treatment that uses melphalan with a specialized Hepatic Delivery System (HDS), in patients with metastatic uveal melanoma (mUM). The data, shared at the European Society for Medical Oncology (ESMO) Congress, evaluated outcomes in different patient subgroups. Researchers compared patients with and without extrahepatic disease, those who were treatment-naive versus previously treated, and those with low versus high liver tumor burden. Results showed no significant differences in overall survival (OS), objective response rate (ORR), or progression-free survival (PFS) between patients with or without extrahepatic lesions or based on prior therapy. However, patients with more extensive liver involvement had lower OS outcomes. These findings support continuing treatment until the best response is achieved and highlight the favorable benefit-risk profile of HEPZATO KIT™ in this challenging patient population.
Read Announcement- Drug:
- HEPZATO KIT
- Announced Date:
- August 27, 2024
- Indication:
- For the treatment of metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc announced the publication of a retrospective study by independent investigators in the Annals of Surgical Oncology.
AI Summary
Delcath Systems, Inc. announced a new publication in the Annals of Surgical Oncology. The retrospective study, conducted by independent investigators at Moffitt Cancer Center, examined the use of the HEPZATO KIT™ for treating liver metastases from uveal melanoma. The research found that patients treated with the HEPZATO KIT experienced improved disease control in the liver and longer progression-free survival compared to those receiving immunotherapy or other liver-directed treatments. In first-line therapy, for example, patients showed a median overall survival of 22.4 months and a median hepatic progression-free survival of 17.6 months. Second-line treatment also yielded promising outcomes. Overall, the study highlights the potential of the HEPZATO KIT as a beneficial treatment option for patients battling metastatic uveal melanoma, offering a promising alternative in the fight against liver-dominant cancer.
Read Announcement - Drug:
- HEPZATO KIT
- Announced Date:
- August 5, 2024
- Indication:
- For the treatment of metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc announced today that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for its HEPZATO KIT™ (melphalan/Hepatic Delivery System).
AI Summary
Delcath Systems, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for its HEPZATO KIT™ (melphalan/Hepatic Delivery System). This NTAP designation, which takes effect for the fiscal year beginning October 1, 2024, is meant to encourage the use of innovative medical treatments that offer significant clinical improvements over current options.
The NTAP approval will help cover the extra costs associated with using HEPZATO KIT in the inpatient setting, ensuring that eligible Medicare patients with liver cancers can access this advanced therapy. The HEPZATO KIT is designed to deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure, and this milestone highlights its clinical value for treating liver cancers, including metastatic uveal melanoma.
Read Announcement- Drug:
- HEPZATO KIT
- Announced Date:
- May 6, 2024
- Indication:
- For the treatment of metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc announced the publication of results from the pivotal Phase 3 FOCUS study of HEPZATO KIT (melphalan/Hepatic Delivery System) in patients with unresectable metastatic Uveal Melanoma (mUM) on May 5, 2024 in the journal Annals of Surgical Oncology.
AI Summary
Delcath Systems, Inc. recently announced the publication of the pivotal Phase 3 FOCUS study results for the HEPZATO KIT (melphalan/Hepatic Delivery System). The study focused on patients with unresectable metastatic Uveal Melanoma (mUM) and provides new insights into treatment options for this challenging condition.
Published on May 5, 2024, in the journal Annals of Surgical Oncology, the study is an important step toward improving outcomes for patients who have limited treatment choices. By using targeted delivery of chemotherapy directly to the liver, the HEPZATO KIT aims to enhance the effectiveness of the treatment while reducing damage to healthy tissue. These published findings may guide future treatment plans and offer new hope for those facing mUM, marking a significant development in the fight against this rare form of melanoma.
Read Announcement
Delcath Systems FDA Events - Frequently Asked Questions
As of now, Delcath Systems (DCTH) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Delcath Systems (DCTH) has reported FDA regulatory activity for HEPZATO KIT.
The most recent FDA-related event for Delcath Systems occurred on April 28, 2025, involving HEPZATO KIT. The update was categorized as "FDA review," with the company reporting: "Delcath Systems, Inc announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC)."
Currently, Delcath Systems has one therapy (HEPZATO KIT) targeting the following condition: For the treatment of metastatic uveal melanoma (mUM)..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:DCTH) was last updated on 7/13/2025 by MarketBeat.com Staff
