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
Melphalan, CHOPIN, and HEPZATO. 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.
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
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:
- 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 - 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
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