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
CHEMOSAT®, HEPZATO, Melphalan, and CHOPIN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
CHEMOSAT® Hepatic Delivery System FDA Regulatory Events
CHEMOSAT® Hepatic Delivery System is a drug developed by Delcath Systems for the following indication: patients with liver-dominant 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:
- CHEMOSAT® Hepatic Delivery System
- Announced Date:
- October 19, 2026
- Indication:
- patients with liver-dominant metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc. announced presentations related to its clinical development programs at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27 in Madrid, Spain.
Read Announcement
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:
- July 9, 2026
- Indication:
- For the treatment of metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc announced that the first patient has been dosed at the European Institute of Oncology (IEO) in Milan, Italy in its global Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (SOC) treatment for liver-dominant metastatic breast cancer (mBC).
AI Summary
Delcath Systems, Inc. said the first patient has been treated at the European Institute of Oncology in Milan, Italy, in its global Phase 2 study of HEPZATO for liver-dominant metastatic breast cancer. The trial is testing HEPZATO together with standard-of-care treatment to see whether the combination can help patients whose cancer has spread mainly to the liver. This marks an important step in the company’s effort to study the therapy in a broader international setting. Delcath is also known for its HEPZATO KIT and CHEMOSAT products, which are designed for targeted treatment approaches. The company said the study is now underway and will help gather more data on safety and possible benefit for patients with this serious form of breast cancer.
Read Announcement- Drug:
- HEPZATO KIT
- Announced Date:
- December 31, 2025
- Indication:
- For the treatment of metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc announced the publication of results from subgroup analyses of the phase 3 FOCUS study.
AI Summary
Delcath Systems announced publication of subgroup analyses from the phase 3 FOCUS study in the Journal of Cancer Research and Clinical Oncology. The paper examined efficacy and safety of the HEPZATO KIT (melphalan/Hepatic Delivery System) in 91 patients with unresectable metastatic uveal melanoma, looking at prespecified groups by age, sex, region, liver tumor extent, hepatic tumor burden, extrahepatic disease, LDH, and prior therapies.
Key findings: overall tumor response was consistent across most subgroups. Patients with tumor burden below the median had a higher ORR (51.1% vs 22.2%, p=0.008) and longer median PFS (11.3 vs 5.8 months, p=0.007). Median OS was longer for patients with smaller liver involvement (22.4 vs 16.8 months, p=0.032), lower tumor burden (26.7 vs 15.4 months, p=0.008) and normal/low LDH (23.4 vs 15.3 months, p=0.019).
Of 33 responders, 57.6% responded by cycle 1–2 and 33.3% in cycles 4–6, supporting treatment through up to six cycles. Safety was similar across subgroups with no cumulative toxicity or treatment-related deaths reported.
Read Announcement- Drug:
- HEPZATO KIT
- Announced Date:
- November 18, 2025
- Indication:
- For the treatment of metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc. announced the publication of a narrative review by leading interventional radiologists and oncologists from multiple institutions.
AI Summary
Delcath Systems announced a narrative review published in the Journal of Vascular and Interventional Radiology by leading interventional radiologists and oncologists from multiple institutions. The paper, titled "Treatment of Liver Metastases from Uveal Melanoma with Percutaneous Hepatic Perfusion," reviews percutaneous hepatic perfusion (PHP) with melphalan using the HEPZATO KIT, covering rationale, technique, patient selection, outcomes, and research directions.
The review synthesizes data from U.S. and European centers showing objective response rates of 36%–72%, median overall survival of 15–20 months, and disease control rates up to 89%. It highlights PHP’s suitability for multifocal, bilobar liver metastases, delivering high-dose chemotherapy with extracorporeal filtration to limit systemic exposure, and notes short hospital stays with many discharges within 24 hours.
Key advantages discussed include lower risk of whole-liver fibrosis versus some alternatives and quality-of-life measures that return to baseline by day 28. The authors encourage further study of immunotherapy combinations and expanding PHP to other liver-dominant cancers like breast and colorectal.
Read Announcement- Drug:
- HEPZATO KIT
- Announced Date:
- August 19, 2025
- Indication:
- For the treatment of metastatic uveal melanoma (mUM).
Announcement
Delcath Systems, Inc. announced that the first patient has been dosed at the City of Hope National Medical Center in its global Phase 2 Clinical Trial evaluating HEPZATO™ in combination with standard of care (SOC) treatment for liver-dominant metastatic colorectal cancer (mCRC).
AI Summary
Delcath Systems, Inc. has begun dosing the first patient at the City of Hope National Medical Center in its global Phase 2 trial of HEPZATO™ combined with standard third-line treatments for liver-dominant metastatic colorectal cancer (mCRC). This randomized, controlled study will enroll about 90 patients at more than 20 sites in the United States and Europe, comparing HEPZATO plus trifluridine-tipiracil and bevacizumab against trifluridine-tipiracil and bevacizumab alone.
The main goal is to measure hepatic progression-free survival (hPFS), with results expected by mid-2028. Overall survival (OS) is a secondary endpoint, anticipated in late 2028. Delcath estimates 6,000 to 10,000 U.S. patients annually could benefit from this new approach, addressing a high unmet need in liver-dominant mCRC.
“Dosing the first patient is an exciting step toward exploring HEPZATO’s potential to provide a new treatment option for patients with metastatic colorectal cancer,” said Vojislav Vukovic, Chief Medical Officer at Delcath Systems, Inc.
Read Announcement- 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
Melphalan (FOCUS) FDA Regulatory Events
Melphalan (FOCUS) is a drug developed by Delcath Systems for the following indication: Ocular melanoma liver metastases.
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:
- Melphalan (FOCUS)
- Announced Date:
- May 7, 2026
- Indication:
- Ocular melanoma liver metastases
Announcement
Delcath Systems, Inc announced that new data from a retrospective analysis by independent investigators on percutaneous hepatic perfusion with melphalan (M-PHP) using the CHEMOSAT® Hepatic Delivery System was presented today at the ESMO Breast Cancer Congress 2026.
AI Summary
Delcath Systems announced new data presented at the ESMO Breast Cancer Congress 2026 from a retrospective analysis of percutaneous hepatic perfusion with melphalan (M-PHP) using the CHEMOSAT Hepatic Delivery System. M-PHP is a liver-directed treatment that delivers high-dose melphalan to the liver while filtering blood to limit drug exposure to the rest of the body. This approach aims to control liver-dominant metastatic breast cancer, which often drives patient decline and limits systemic therapy options.
Independent investigators at three European centers reviewed 15 patients treated with M-PHP, assessing feasibility, safety, and tumor response by RECIST v1.1. Delcath’s CEO said the results provide real-world evidence supporting use of the HEPZATO KIT and CHEMOSAT and highlight the need for further study in heavily pretreated patients. HEPZATO KIT is also being tested in a randomized Phase 2 trial for liver-dominant metastatic breast cancer (PHP-MBC-202, NCT06875128). In Europe, CHEMOSAT is approved as a Class III device for use in M-PHP procedures.
Read Announcement
CHOPIN FDA Regulatory Events
CHOPIN is a drug developed by Delcath Systems for the following indication: for percutaneous hepatic perfusion with melphalan in patients with metastatic uveal melanoma.
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:
- CHOPIN
- Announced Date:
- March 3, 2026
- Indication:
- for percutaneous hepatic perfusion with melphalan in patients with metastatic uveal melanoma.
Announcement
Delcath Systems, Inc announced the publication of the full results from the investigator-initiated CHOPIN randomized Phase 2 clinical trial, led by Principal Investigator Professor Ellen Kapiteijn, MD, from Leiden University Medical Center's Department of Medical Oncology.
AI Summary
Delcath Systems, Inc. announced publication of the full results from the investigator‑initiated CHOPIN randomized Phase 2 trial, led by Prof. Ellen Kapiteijn, MD, of Leiden University Medical Center. The study tested percutaneous hepatic perfusion (PHP) combined with the immunotherapies ipilimumab and nivolumab in patients with metastatic uveal melanoma.
In the intention‑to‑treat population the authors reported an acceptable safety profile and encouraging signs of clinical activity. Overall, they conclude the PHP plus immunotherapy approach shows promise as a new treatment option for this hard‑to‑treat cancer and warrants further study.
The announcement also noted Delcath’s hepatic delivery system (HDS) is marketed in Europe as CHEMOSAT for melphalan delivery and has been used at major centers to perform PHP procedures for liver cancers.
Read Announcement- Drug:
- CHOPIN
- Announced Date:
- September 22, 2025
- Indication:
- for percutaneous hepatic perfusion with melphalan in patients with metastatic uveal melanoma.
Announcement
Delcath Systems, Inc announced the acceptance of an oral presentation on results from the investigator-initiated CHOPIN randomized Phase 2 trial at the 2025 European Society for Medical Oncology (ESMO) Annual Congress.
AI Summary
Delcath Systems, Inc. announced the acceptance of an oral presentation on results from the investigator-initiated CHOPIN randomized Phase 2 trial at the 2025 European Society for Medical Oncology (ESMO) Annual Congress. Principal Investigator Ellen Kapiteijn, MD, from Leiden University Medical Center will share data on the safety, tolerability, and efficacy of sequencing systemic ipilimumab and nivolumab with Delcath’s CHEMOSAT® Hepatic Delivery System for percutaneous hepatic perfusion with melphalan in metastatic uveal melanoma patients.
The CHOPIN study, titled “Combined Percutaneous Hepatic Perfusion with Ipilimumab plus Nivolumab in Metastatic Uveal Melanoma,” is a single-center, open-label, randomized trial. It tests whether isolating and filtering liver blood during high-dose melphalan infusion can improve tumor response while reducing systemic side effects when combined with immune checkpoint inhibitors.
The oral session (Abstract LBA59) is scheduled for Saturday, October 18, 2025 at 3:20 p.m. CET (9:20 a.m. EST) under “Melanoma and Other Skin Tumours.” A poster will be posted on Delcath’s website after the ESMO embargo lifts on October 18.
Read Announcement
