Drugs / Melphalan
Melphalan
also known as
L-PAM · Mel · Melphalan hydrochloride · Melfalan · Melphalan=Alkeran · alkeran · Melphalan HCL · Evomela · +24 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 2 milestones | |||||
| Filed | China (NMPA) | EVOMELA | plasma cell myeloma | 2016-12-05 | “CASI Pharmaceuticals' Import Drug Registration Application For EVOMELA® Accepted For Review By CFDA” issuerdirect.com ↗ |
| Filed | US (FDA) | EVOMELA | plasma cell myeloma | 2015-05-11 | “Spectrum Pharmaceuticals announced that its NDA for Captisol-Enabled Melphalan was accepted by the FDA and assigned a PDUFA date of October 23, 2015.” ligand.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | EU (EMA) | Phelinun | — | 2020-11-16 | europa.eu ↗ |
| Rejected (CRL) | US (FDA) | Melblez Kit | ocular melanoma metastatic to the liver | 2013-09-12 | “FDA has issued a complete response letter (CRL) received September 12, 2013 regarding the New Drug Application (NDA) for Delcath's Melblez TM Kit” delcath.com ↗ |
| Approved | US (FDA) | ALKERAN | — | 1964-01-17 | fda.gov ↗ |
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EU approved 2020
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News releases announcing trial results or a regulatory action · 92
| Date | Issuer | Release |
|---|---|---|
| 2026-03-03 | Delcath Systems Inc. | Results Delcath Systems Announces Publication of CHOPIN Clinical Trial Results in The Lancet Oncology delcath.com ↗
By more than tripling the 1-year progression-free survival rate and nearly doubling the 2-year overall survival, these results strongly underscore the clinical value of this combination and give us even greater confidence in adoption by treating physicians and patients. |
| 2025-12-31 | Delcath Systems Inc. | Results Delcath Systems Announces Publication of Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma delcath.com ↗
Delcath Systems, Inc. (Nasdaq: DCTH), (“Delcath” or the “Company”) an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of results from subgroup analyses of the phase 3 FOCUS study. |
| 2025-12-03 | Delcath Systems Inc. | Results Delcath Systems Announces Publication of 10-Year Single-Center Experience with Percutaneous Hepatic Perfusion in Liver-Dominant Metastatic Uveal Melanoma delcath.com ↗
The article highlights the procedure’s safety and efficacy, demonstrating a median overall survival (OS) of 29.1 months from the first PHP treatment, with improved outcomes associated with additional treatment cycles. |
| 2025-11-18 | Delcath Systems Inc. | Results Delcath Systems Announces Publication of Expert Narrative Review on Percutaneous Hepatic Perfusion for Liver Metastases from Uveal Melanoma delcath.com ↗
By consolidating insights from leading specialists, this review reinforces the value of HEPZATO KIT in achieving meaningful tumor responses and survival benefits while preserving quality of life. |
| 2025-11-13 | Delcath Systems Inc. | Results Delcath Systems Announces Publication of Real-World Evidence Supporting Early Use of Liver-Directed Therapy with PHP in Achieving Long-Term Survival for Metastatic Uveal Melanoma Patients delcath.com ↗
today announced the publication of results from a retrospective analysis conducted by researchers at the University of Tubingen , Germany . |
| 2025-10-18 | Delcath Systems Inc. | Results Delcath Systems Announces Investigator-Initiated CHOPIN Clinical Trial Meets Primary Endpoint delcath.com ↗ |
| 2025-04-09 | Delcath Systems Inc. | Results Delcath Systems Announces Publication of Comparative Analysis from Randomized Portion of FOCUS Study in Metastatic Uveal Melanoma delcath.com ↗
Median progression-free survival in patients treated with Melphalan/HDS was 9.1 months, nearly three times longer than the 3.3 months observed in patients treated with BAC |
| 2025-03-06 | Delcath Systems Inc. | Regulatory Delcath Systems Reports Fourth Quarter and Full Year 2024 Results delcath.com ↗
Received FDA Clearance of an IND Application for a Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Colorectal Cancer |
| 2024-12-02 | Delcath Systems Inc. | Regulatory Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Colorectal Cancer delcath.com ↗
Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today 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). |
| 2024-09-16 | Delcath Systems Inc. | Results Delcath Systems Announces New Data Presented at ESMO 2024 Demonstrating Efficacy of HEPZATO KIT™ in Metastatic Uveal Melanoma Subgroups delcath.com ↗
There were no significant differences in OS, ORR, or PFS between patients with and without extrahepatic lesions or based on prior therapy. |
| 2024-08-28 | Delcath Systems Inc. | Results Delcath Systems, Inc. Announces Positive Results from Independent Study on Liver-Directed Therapy for Uveal Melanoma Patients delcath.com ↗
The study demonstrates that first-line liver-directed therapies, including Delcath’s CHEMOSAT ® Hepatic Delivery System, significantly improve melanoma-specific survival (MSS) in patients with liver metastases from uveal melanoma, compared to first-line systemic therapies. |
| 2024-08-27 | Delcath Systems Inc. | Results Delcath Systems, Inc. Announces Positive Outcomes from Independent Study on Hepatic Perfusion for Uveal Melanoma Patients delcath.com ↗
The 30-patient study reported that Delcath’s HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) provided better disease control in the liver and improved progression-free survival in patients with hepatic metastases from uveal melanoma, compared to both immunotherapy and other liver-directed therapies. |
| 2024-08-26 | Delcath Systems Inc. | Results Delcath Systems, Inc. Announces Promising Results from Independent Study on Repeated Hepatic Chemosaturation for Liver Tumors delcath.com ↗
The study, titled “Hepatic chemosaturation with melphalan in patients with primary or secondary liver tumors with or without extrahepatic tumor manifestation,” highlights the efficacy and safety of repeated chemosaturation treatments using Delcath’s CHEMOSAT ® Hepatic Delivery System. |
| 2024-05-06 | Delcath Systems Inc. | Results Publication of Results from Pivotal FOCUS Study in Metastatic Uveal Melanoma Patients treated with HEPZATO KIT delcath.com ↗
The primary efficacy endpoint of the FOCUS study was Overall Response Rate (ORR), which was 36.3%, including 7.7% of patients with Complete Response (CR), as determined by an Independent Review Committee. |
| 2024-03-26 | Delcath Systems Inc. | Results Delcath Systems Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update delcath.com ↗
A clinical study entitled "Quality of Life After Melphalan Hepatic Perfusion for Uveal Melanoma" in which the authors concluded utilizing Delcath's CHEMOSAT to administer high-dose melphalan to the liver is well tolerated by patients and does not negatively affect their quality of life. |
| 2023-12-07 | Delcath Systems Inc. | Results Delcath Systems Announces Publication by Independent Investigators of a Retrospective Analysis of Quality of Life in the Journal Melanoma Research delcath.com ↗
Results Support that Utilizing Delcath's HDS to Administer High-Dose Melphalan to the Liver Is Well Tolerated by Patients |
| 2023-10-16 | Delcath Systems Inc. | Results Delcath Systems Announces a Comparative Study of Chemosat and SIRT Published in the Journal Cancers delcath.com ↗
Significantly Longer Overall Survival for Patients Treated with Chemosat vs. SIRT (17 and 9.9 months, respectively; p=0.006) |
| 2023-09-11 | Delcath Systems Inc. | Results A Retrospective Comparative Study of Chemosat and SIRT Presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting delcath.com ↗
Median overall survival (mOS) was 301 days for SIRT and 516 days for CS-PHP, the adjusted Cox regression analysis showed a significant difference (p=0.006). |
| 2023-08-14 | Delcath Systems Inc. | Regulatory Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma delcath.com ↗ |
| 2023-05-12 | Delcath Systems Inc. | Results Delcath Systems Provides Business Update and Reports Preliminary First Quarter 2023 Financial Results delcath.com ↗
The article reported seven patients with advanced uveal melanoma treated with CHEMOSAT and ipilimumab plus nivolumab showed a median PFS of 29.1 months at a median follow-up of 29.1 months. |
| 2023-03-27 | Delcath Systems Inc. | Regulatory Delcath Systems, Inc. Announces FDA Acceptance of New Drug Application Resubmission of Hepzato Kit with a PDUFA Date of August 14, 2023 delcath.com ↗ |
| 2023-02-14 | Delcath Systems Inc. | Regulatory Delcath Systems Announces New Drug Application Resubmission for HEPZATO Kit delcath.com ↗ |
| 2023-01-17 | Delcath Systems Inc. | Results Delcath Systems Announces Updated Results from CHOPIN Phase 1b Trial Published in Cardiovascular and Interventional Radiology delcath.com ↗
Updated results in seven patients with advanced uveal melanoma treated with CHEMOSAT and ipilimumab plus nivolumab show a Median PFS of 29.1 months |
| 2022-12-05 | Delcath Systems Inc. | Results Results of a Single Center Study on Delcath's CHEMOSAT® Hepatic Delivery System In the Treatment of Cholangiocarcinoma Published in the Journal Clinical & Experimental Metastasis delcath.com ↗
After the first PHP, one patient (6%) presented with a complete response (CR). |
| 2022-08-05 | Delcath Systems Inc. | Results Results of a Multicenter Study on Delcath's CHEMOSAT® Hepatic Delivery System Published in Cardiovascular and Interventional Radiology delcath.com ↗
Retrospective study in metastatic uveal melanoma patients with liver dominant disease shows an objective response rate of 59.4% and a disease control rate of 89.1%. |
| 2022-06-06 | Delcath Systems Inc. | Results Positive Initial Results from CHOPIN Phase 1b Trial, FOCUS Trial Update and QoL Study Presented at the 2022 ASCO Annual Meeting delcath.com ↗
Initial results from the Phase 1b portion of the CHOPIN trial of PHP in combination with ipilimumab plus nivolumab in advanced uveal melanoma in seven patients resulted in 85.7% Best Overall Response and 100% Disease Control Rate. |
| 2022-02-03 | Delcath Systems Inc. | Results Results of Single Center Study on Delcath’s CHEMOSAT® Hepatic Delivery System Published in Melanoma Research delcath.com ↗
Retrospective Study by University Hospital Southampton in metastatic uveal melanoma (mUM) patients with liver dominant disease shows hepatic disease control rate of 88.9%, hepatic response rate of 66.7% and overall response rate of 60.5% |
| 2021-12-02 | Delcath Systems Inc. | Results Delcath Systems, Inc. Announces Positive Phase 3 FOCUS Trial Results for Hepzato™ in Liver-Dominant Metastatic Ocular Melanoma, Including Initial Survival Data Analysis delcath.com ↗
Treatment with HEPZATO in the ITT analysis resulted in an objective-response-rate (ORR) of 31.4% [95% CI: 22.55-41.31], including 6.9% of patients with a complete response (CR). |
| 2021-06-07 | Delcath Systems Inc. | Results Positive Preliminary Results from Delcath Systems’ FOCUS Trial Presented at the 2021 ASCO Annual Meeting delcath.com ↗
Delcath Systems, Inc. (Nasdaq: DCTH ), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced an oral presentation of positive preliminary efficacy results from its FOCUS Phase III trial of HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system) in patients with liver dominant metastatic ocular melanoma (mOM) at the American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually June 4-8, 2021 . |
| 2021-04-21 | Delcath Systems Inc. | Regulatory Delcath Systems, Inc. Announces Revised NICE Guidance for CHEMOSAT in the United Kingdom delcath.com ↗
Under the revised NICE guidance, CHEMOSAT has been categorized under a Special Arrangement designation. |
| 2021-03-31 | Delcath Systems Inc. | Results Delcath Systems, Inc. Shares Additional Information Regarding FOCUS Trial Power Calculation delcath.com ↗
A preliminary analysis of 87% of enrolled patients analyses by the Independent Review Committee yielded an ORR of 29.2% [95% CI: 20.1, 39.8] in the Intent to Treat population, which substantially exceeds the 21.0%-point-estimate requirement. |
| 2021-03-31 | Delcath Systems Inc. | Results Delcath Systems, Inc. Announces Positive Preliminary Results from Phase 3 FOCUS Trial of HEPZATO in Patients with Metastatic Ocular Melanoma delcath.com ↗ |
| 2021-03-31 | Delcath Systems Inc. | Results Delcath Systems, Inc. Announces Fourth Quarter 2020 Results, Highlights Preliminary Positive FOCUS Trial Results; Conference Call Today at 8:00am Eastern Time delcath.com ↗
The primary endpoint, overall response rate (ORR), as determined by an independent review committee, exceeded the prespecified threshold for success. |
| 2020-10-29 | Delcath Systems Inc. | Results Delcath Systems Announces a KOL Call on November 5, 2020 to discuss the Results of a Prospective Phase II Study in Patients with Metastatic Ocular Melanoma delcath.com ↗
The overall response rate observed in these earlier stage patients was 72% (complete response of 3% and partial response of 69%) with a median overall survival of 19.1 months. |
| 2019-12-09 | Janssen Research & Development, LLC | Results DARZALEX® (Daratumumab) Shows Overall Survival Benefit and Continued Improvement in Progression-Free Survival in Patients with Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplant jnj.com ↗
These updated data from the ALCYONE study also demonstrated that the addition of DARZALEX®to VMP resulted in higher rates of minimal residual disease (MRD) negativity. |
| 2019-07-22 | Delcath Systems Inc. | Results Results of Single Center Study on Delcath’s PHP Therapy Published in Cancer Imaging delcath.com ↗
Median progression free survival (PFS) after the first treatment was 11.1 months. |
| 2019-04-16 | Delcath Systems Inc. | Results Results of Single Center Prospective Study on Delcath’s PHP Therapy Presented at ECIO 2019 delcath.com ↗
Results of the study showed that one patient had a complete response and 22 had partial response, for a combined overall response rate of 74.1%. |
| 2018-12-18 | Delcath Systems Inc. | Results Delcath Announces 4th Independent Safety Review of Registration Trial Data for Metastatic Ocular Melanoma: Recommended Continuation with no Trial Modification delcath.com ↗
The DSMB again recommended continuation of the study without modification. |
| 2018-12-03 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Announces China Market Approval Of Melphalan Hydrochloride For Injection (Trademark: EVOMELA®) issuerdirect.com ↗
The NMPA approved Melphalan Hydrochloride For Injection (EVOMELA®) under its new priority review guidelines. |
| 2018-10-04 | Delcath Systems Inc. | Results Multi-center Analysis of Outcomes Data on Use of Delcath CHEMOSAT in the Treatment of ICC Published in European Radiology delcath.com ↗
Results of the study showed that after the first PHP treatment, one patient (7%) has a complete response (CR), two patients (13%) had a partial response (PR), and stable disease (SD) was observed in eight patients (53%). |
| 2018-09-26 | Delcath Systems Inc. | Results Data from Prospective Phase 2 Study Investigating Delcath’s PHP Therapy presented at CIRSE 2018 delcath.com ↗
Results of the study, according to RECIST 1.1, showed that a complete response was observed in one patient (3.1%) and a partial response was observed in 21 patients (65.6%), resulting in an objective response rate of 68.7%. |
| 2018-09-24 | Delcath Systems Inc. | Results Data on Delcath’s PHP Therapy presented at CIRSE 2018 delcath.com ↗
Results of the study showed the objective response rate (ORR) was 58.3%, and the disease control rate was 91.7% (1 complete response, 6 partial responses, 4 stable disease, and 1 progressive disease). |
| 2018-08-23 | Delcath Systems Inc. | Results Delcath Announces 3rd Independent Safety Review of Randomized Trial Data for Metastatic Ocular Melanoma; Recommended Continuation with no Trial Modification delcath.com ↗
The DSMB again recommended that no safety related modifications to the treatment protocol be made. |
| 2018-04-05 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Provides Update On EVOMELA® issuerdirect.com ↗
CASI Receives Advisory Meeting Notice from China Center for Drug Evaluation |
| 2018-03-29 | Delcath Systems Inc. | Results Summary of Recent Published Research on Delcath’s PHP Therapy Presented at Society of Surgical Oncology Annual Symposia delcath.com ↗
Karydis showed an overall response rate with PHP of 47%, a >84% disease control rate and hPFS of 9.1 months. |
| 2018-01-10 | Delcath Systems Inc. | Regulatory Delcath Announces Special Protocol Agreement Modification With FDA delcath.com ↗
The modification agreement revises the FOCUS trial’s eligibility criteria to permit a greater extent of extra-hepatic disease by removing the size restriction, number and location of extra-hepatic lesions, in conjunction with a treatment plan for the extra-hepatic metastases. |
| 2018-01-09 | Delcath Systems Inc. | Results Positive Results From a Multi-Center Analysis of Delcath PHP Therapy Published in Journal of Surgical Oncology delcath.com ↗
Results showed that of the 51 treated patients, 22 (43.1%) showed a partial response, 3 (5.9%) showed a complete response, and 17 (33.3%) had stable disease. |
| 2017-12-19 | Delcath Systems Inc. | Results Delcath Announces Preliminary Safety Analysis for Phase 3 Focus Trial delcath.com ↗
The DSMB has recommended that the study continue without modification. |
| 2017-12-12 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab) Combination Regimen Significantly Improved Outcomes for Newly Diagnosed Multiple Myeloma Patients who are Transplant Ineligible jnj.com ↗
Phase 3 ALCYONE data showed DARZALEX in combination with bortezomib, melphalan and prednisone meaningfully improved progression-free survival and response rates |
| 2017-12-05 | Delcath Systems Inc. | Results Favorable Results from a Multi-Center Analysis of Delcath PHP Therapy to be Published in Journal of Surgical Oncology delcath.com ↗
Preliminary results of the study presented at the Regional Therapies conference earlier this year showed data indicating tumor response and overall survival benefit with PHP Therapy beyond the 6-8 months seen with other therapies in this patient population. |
| 2017-09-19 | Delcath Systems Inc. | Results Data on Delcath’s CHEMOSAT System Presented at CIRSE Annual Meeting delcath.com ↗
Results of the study showed the GEN2 CHEMOSAT system had an overall efficiency of 86%, with efficiency highest at the time of highest concentration of melphalan in the blood and declining as melphalan blood concentration declined. |
| 2017-09-07 | CASI pharmaceuticals, Inc. | Regulatory CASI Provides Pipeline Development Update issuerdirect.com ↗
China's Food and Drug Administration (CFDA) has granted priority review for CASI's import drug registration clinical trial application for EVOMELA (melphalan) for Injection. |
| 2017-03-27 | Delcath Systems Inc. | Regulatory Delcath Announces Special Protocol Assessment Agreement With FDA for Pivotal Trial With Melphalan/HDS in Intrahepatic Cholangiocarcinoma delcath.com ↗
The SPA agreement indicates that the pivotal trial design adequately addresses objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS. |
| 2017-02-22 | Delcath Systems Inc. | Results Published Review Shows Delcath Investigational PHP Doubles Overall Survival Over Other Targeted Liver Therapies delcath.com ↗ |
| 2017-02-21 | Delcath Systems Inc. | Results Analysis From Two Institutions Shows Strong Tumor Response, Overall Survival Potential of Delcath Investigational PHP Therapy delcath.com ↗
The study further showed that among those who responded to treatment, overall survival was projected to be more than three years. |
| 2016-12-05 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals' Import Drug Registration Application For EVOMELA® Accepted For Review By CFDA issuerdirect.com ↗
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announced today that China's Food and Drug Administration (CFDA) has accepted for review the Company's import drug registration application for EVOMELA® (melphalan) for Injection. |
| 2016-09-27 | Amgen | Results Amgen Announces Top-Line Results From Phase 3 KYPROLIS® (Carfilzomib) CLARION Study In Newly Diagnosed Multiple Myeloma Patients amgen.com ↗
The trial did not meet the primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 percent CI, 0.75 - 1.10). |
| 2016-09-14 | Delcath Systems Inc. | Results Data Supporting CHEMOSAT Presented at the Cardiovascular and Interventional Radiology Society of Europe Conference delcath.com ↗
The investigators concluded that patients with primary or secondary liver tumors that have disease progression under standard therapy “may profit from PHP with Melphalan,” that technical execution is problem-free, and complications are manageable. |
| 2016-03-15 | Ligand Pharmaceuticals | Regulatory Ligand Partner Spectrum Pharmaceuticals Receives FDA Approval of EVOMELA™ (melphalan) for Injection ligand.com ↗
Ligand Partner Spectrum Pharmaceuticals Receives FDA Approval of EVOMELA™ (melphalan) for Injection |
| 2016-01-19 | Delcath Systems Inc. | Regulatory Delcath Announces Special Protocol Assessment Agreement With FDA For New Phase 3 Trial In Hepatic Dominant Ocular Melanoma delcath.com ↗
The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that, if met, would support the submission for regulatory approval of Melphalan/HDS. |
| 2016-01-11 | Delcath Systems Inc. | Results Review of Delcath Melphalan/HDS System Published in "Cardiovascular & Interventional Radiology" delcath.com ↗
In their update of current literature on percutaneous hepatic perfusion, the LUMC team noted that the current version of the Delcath product and procedure "appear to have reduced the rate and severity of bone marrow suppression" over the previous version of the system. |
| 2015-12-09 | Delcath Systems Inc. | Results Delcath Prior Phase 3 Trial Results Published In Annals Of Surgical Oncology delcath.com ↗ |
| 2015-09-30 | Delcath Systems Inc. | Results Data Supporting Delcath's Chemosat System Presented At The Cardiovascular and Interventional Radiology Society Annual Meeting delcath.com ↗
Results showed grade 3 complications (mostly asymptomatic leukocytopenia and thrombocytopenia) in seven patients, and febrile neutropenia with bacterial pharyngitis in one patient. |
| 2015-09-28 | Delcath Systems Inc. | Results Retrospective Study Examining Delcath's CHEMOSAT And Isolated Hepatic Perfusion Presented At ECCO Annual Meeting delcath.com ↗
In the IHP cohort (30 patients treated between March 1999 and April 2009 ) progression free survival was 6 months and recurrence was mainly in the liver, and overall survival was 10 months. |
| 2015-07-20 | Delcath Systems Inc. | Regulatory Delcath Receives Orphan Drug Designation From FDA For Melphalan To Treat Cholangiocarcinoma delcath.com ↗
the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation for melphalan for the treatment of cholangiocarcinoma. |
| 2015-05-29 | Delcath Systems Inc. | Results Positive Data With Delcath's CHEMOSAT Highlighted At ASCO 2015 delcath.com ↗
Radiologically, 2 patients (10%) demonstrated stable disease for >3 months, 13 patients (65%) had a partial response in the liver with complete responses in 2 patients (10%). |
| 2015-04-21 | Delcath Systems Inc. | Regulatory Delcath Receives Approval To Expand Global Phase 2 HCC Program To Include Patients With Intrahepatic Cholangiocarcinoma delcath.com ↗ |
| 2015-03-27 | Delcath Systems Inc. | Results Data Highlighting Delcath's Melphalan/HDS Presented At The Society Of Surgical Oncology Annual Meeting delcath.com ↗
The data were presented by Andrea Abbott , M.D., Surgical Oncology, Moffitt Cancer Center in a poster titled "Hepatic Progression Free and Overall Survival after Regional Therapy to the Liver for Metastatic Melanoma" as part of the Melanoma and Sarcoma Session at the meeting. |
| 2013-10-01 | Delcath Systems Inc. | Regulatory U.S. FDA GRANTS ORPHAN DRUG DESIGNATION TO DELCATH SYSTEMS FOR USE OF MELPHALAN HYDROCHLORIDE IN HCC delcath.com ↗
Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology, announced today that the U.S. Food & Drug Administration (FDA) has granted the Company orphan drug designation for melphalan in the treatment of patients with hepatocellular carcinoma (HCC, or primary liver cancer). |
| 2013-09-13 | Delcath Systems Inc. | Regulatory DELCATH RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR MELBLEZTM KIT NEW DRUG APPLICATION delcath.com ↗
A CRL is issued by the FDA when the review of a file is completed and questions remain that precludes approval of the NDA in its current form. |
| 2013-05-02 | Delcath Systems Inc. | Regulatory DELCATH PROVIDES UPDATE ON FDA ADVISORY COMMITTEE MEETING ON MELBLEZTM KIT delcath.com ↗
The FDA is not bound by the recommendation of its advisory committee, but will consider the committee's guidance as it evaluates the Melblez Kit New Drug Application (NDA). |
| 2013-04-08 | Delcath Systems Inc. | Regulatory DELCATH RECEIVES NOTIFICATION OF PDUFA DATE EXTENSION delcath.com ↗
As the information was requested and supplied within 90 days of the June 15, 2013 PDUFA goal date, the agency exercised its option to extend the PDUFA goal date to provide adequate time for completion of its review. |
| 2012-11-05 | Delcath Systems Inc. | Regulatory DELCATH RECEIVES REGULATORY APPROVAL FOR THE GENERATION TWO HEPATIC CHEMOSAT® DELIVERY SYSTEM IN AUSTRALIA delcath.com ↗
Delcath Systems, Inc. (NASDAQ: DCTH) today announced the Therapeutic Goods Administration (TGA) division of the Australian government has approved the Generation Two Hepatic CHEMOSAT ® Delivery system for melphalan hydrochloride for listing on the Australian Register of Therapeutic Goods (ARTG). |
| 2012-11-01 | Delcath Systems Inc. | Regulatory DELCATH ANNOUNCES JUNE 15, 2013 PDUFA GOAL DATE FOR NEW DRUG APPLICATION delcath.com ↗
Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2013, for substantive review of the Company's New Drug Application (NDA) of its proprietary chemosaturation system with melphalan hydrochloride for injection. |
| 2012-10-15 | Delcath Systems Inc. | Regulatory DELCATH ANNOUNCES FDA ACCEPTS NEW DRUG APPLICATION FOR ITS PROPRIETARY CHEMOSATURATION SYSTEM WITH MELPHALAN HYDROCHLORIDE delcath.com ↗
Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for its proprietary chemosaturation system with melphalan hydrochloride for injection. |
| 2012-08-15 | Delcath Systems Inc. | Regulatory Delcath Submits New Drug Application For Proprietary Chemosaturation System To The U.S. Food And Drug Administration delcath.com ↗
Delcath Systems, Inc. (NASDAQ: DCTH) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for the Company's proprietary chemosaturation system for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. |
| 2012-06-05 | Delcath Systems Inc. | Results Post-Hoc Analysis Of Delcath's Phase 3 Trial Presented At ASCO delcath.com ↗
The analysis found that as measured by the trial's primary endpoint of hepatic progression free survival (hPFS), the BAC-cross over arm of the study was consistent with the hPFS achieved in patients randomized directly to the chemosaturation arm. |
| 2012-04-26 | Delcath Systems Inc. | Results Low Side Effects Seen in Treatment With Delcath's Second Generation Hemofiltration Cartridge delcath.com ↗
Treatment with the second-generation CHEMOSAT system showed brief mild bone marrow suppression and no significant related toxicities. |
| 2012-02-02 | Ligand Pharmaceuticals | Results Ligand Presents Full Data from Successful Phase II Trial of Captisol-Enabled®, Propylene Glycol-Free Melphalan at the BMT Tandem Meetings ligand.com ↗
The Phase II study successfully met all endpoints. |
| 2011-09-25 | Delcath Systems Inc. | Results Delcath Announces Further Results From Neuroendocrine Tumor Cohort Presented at European Multidisciplinary Cancer Congress delcath.com ↗
Dr. Pingpank will also present the updated hepatic response rate of 70% in 20 evaluable patients, and median overall survival of 30.4 months in all 24 patients on an intent-to-treat basis, as presented at CIRSE. |
| 2011-09-23 | Delcath Systems Inc. | Results Delcath Announces Updated Efficacy Results From Phase 3 Trial of Chemosaturation for Melanoma Metastases in the Liver Presented at European Multidisciplinary Cancer Congress delcath.com ↗
Median overall PFS in the chemosaturation arm was 6.7 months compared to 1.6 months in the BAC arm, an increase of 5.1 months (hazard ratio 0.36, p<0.0001). |
| 2011-09-12 | Delcath Systems Inc. | Results Positive Phase 2 Trial Results From Neuroendocrine Tumor Cohort Presented at CIRSE delcath.com ↗
The primary endpoint of overall hepatic response rate (ORR) among the 20 evaluable patients was 70%, including one patient who presented with a confirmed complete response (CR) and 13 with confirmed partial responses (PR). |
| 2011-09-01 | Delcath Systems Inc. | Results Delcath Announces Top-Line Results From Metastatic Colorectal Cohort in Phase II Trial of Chemosaturation System delcath.com ↗
Delcath Systems, Inc. (NASDAQ: DCTH) reported top-line results from the metastatic colorectal (adenocarcinoma) cohort of the Phase II clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer. |
| 2011-08-22 | Delcath Systems Inc. | Results Delcath Announces Encouraging Top-Line Results From Hepatobiliary Cohort in Phase II Trial of Chemosaturation System delcath.com ↗
Delcath Systems, Inc. (NASDAQ: DCTH) reported encouraging top-line results from the hepatobiliary cohort of the Phase II clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer. |
| 2011-06-06 | Ligand Pharmaceuticals | Results Ligand Presents Phase IIa Data on Captisol(R)-Enabled, Propylene Glycol-Free Melphalan at ASCO 2011 ligand.com ↗
PK analysis revealed that the new propylene glycol-free Melphalan met the requirements for establishment of bioequivalence to Alkeran |
| 2011-04-13 | Delcath Systems Inc. | Regulatory Delcath Receives Notice of European Regulatory Approval for Hepatic CHEMOSAT(TM) Delivery System delcath.com ↗
Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the Company has been notified of CE Mark approval for its proprietary Hepatic CHEMOSAT(TM) Delivery System. |
| 2011-02-22 | Delcath Systems Inc. | Regulatory Delcath Systems Receives Refusal to File Letter From FDA delcath.com ↗ |
| 2010-12-22 | Delcath Systems Inc. | Regulatory Delcath Completes New Drug Application Submission to the FDA for the Chemosaturation Delivery System delcath.com ↗ |
| 2010-06-05 | Delcath Systems Inc. | Results Delcath Highlights Phase III Trial Results Presented at ASCO delcath.com ↗
In the PHP arm of the study, patients showed median hepatic progression free survival (hPFS) of 245 days compared to 49 days in the BAC arm, a 5x extension of hPFS. |
| 2010-04-21 | Delcath Systems Inc. | Results Delcath Phase III Trial Results Exceed Primary Endpoint Expectations delcath.com ↗
This reflects a 144-day prolongation of hPFS over that of BAC control arm, with less than half the risk of progression and/or death in the PHP group compared to the BAC group (Hazard Ratio = 0.46). |
| 2010-02-16 | Delcath Systems Inc. | Regulatory Delcath to Initiate Expanded Access Treatment Program for PHP System With Melphalan delcath.com ↗
Under the Expanded Access Program, the five centers treating the highest number of patients during the Phase III trial may continue to treat patients with metastatic melanoma to the liver while the data is being evaluated. |
| 2009-06-02 | Delcath Systems Inc. | Regulatory Delcath Systems Granted Third Orphan Drug Designation delcath.com ↗ |
All press releases naming this drug 125 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 125 releases opens the full record — a long page | ||
Evidence & citations 36 cited values
Every value below carries the sentence it was read from. 780 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Melphalan | “Induction:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Stem Cell harvest: HD Cyclophosphamide Intensification: HD Melphalan...” NCT02405364 ↗764“Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an...” NCT00145626 ↗ “Twenty-two children with a median age of 2.8 years, many with severe comorbidities and prior viral infections, were enrolled in a novel RIC protocol consisting of hydroxyurea,...” PMID 24296492 ↗ Dec 2013 “The investigator prospectively evaluated the combination of Rituximab and Dexa-BEAM (dexamethasone, carmustine, etoposide, cytarabine, melphalan) followed by high dose therapy...” NCT02099292 ↗ “Clinical and safety outcomes of BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) versus CEM (Carboplatin, Etoposide, Melphalan) in lymphoma patients as a conditioning...” PMID 39134959 ↗ Aug 2024 “Haploidentical stem cell transplant recipients will receive a reduced intensity conditioning regimen consisting of OKT-3, Fludarabine, Thiotepa , and Melphalan followed by an...” NCT00145587 ↗ “High Dose Melphalan and Autologous Hematopoietic Cell Transplantation Patients will receive Melphalan 200 mg/m2 per institutional guidelines, or if over 70 years of age or...” NCT03556332 ↗ “Transplant recipients received a reduced intensity conditioning regimen consisting of OKT-3, fludarabine, thiotepa, and melphalan followed by an infusion of a T-cell depleted...” NCT00143559 ↗ “Patients will receive busulfan twice daily on Days - 8, -7, -6, and -5 and Melphalan on Days -4, -3 and -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1 with stem...” NCT01049854 ↗ “Once the patient recovers, the patient will be evaluated again and will then undergo a second stem cell transplant consisting of the chemotherapy drugs; Melphalan,...” NCT00179816 ↗ “Conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2.” NCT00772811 ↗ |
| Known as | Alanine nitrogen mustard | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | alkeran | “Carmustine (B) also known as BCNU Etoposide (E) Cytarabine (A) also known as Ara-C and cytosine arabinoside Melphalan (M) also known as alkeran” NCT00574509 ↗ |
| Known as | Alkeran hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | CB 3025 | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | CB 3025 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | Evomela | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03159702 ↗ |
| Known as | HDMEL | “High-dose chemotherapy using melphalan (HDMEL) is an important component of many conditioning regimens that are given before autologous hematopoietic stem cell transplantation (AHSCT).” PMID 14767498 ↗ Apr 2004 |
| Known as | Hepzato | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | Ivra | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | L-PAM | “Patients receive melphalan (L-PAM) intrathecally (IT) via lumbar puncture or Ommaya reservoir twice a week for 2 weeks.” NCT00002750 ↗9“The combination of whole body hyperthermia (WBH) and melphalan (L-PAM) is administered on week 1.” NCT00002973 ↗ “Hyperthermic intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.” NCT00001296 ↗ “oral melphalan (L-PAM) and oral cyclophosphamide (CTX) on days 22-25 (ABCM)” NCT00002653 ↗ “Following 4 weeks of rest, melphalan (L-PAM) is administered over 1 hour.” NCT00003007 ↗ “melphalan (L-PAM) before or after total body irradiation (TBI)” NCT00003815 ↗ “high-dose melphalan (L-PAM)” NCT00025064 ↗ “NSC-614629 L-PAM Melphalan” NCT00002630 ↗ “NSC-326231 L-PAM Melphalan” NCT00002730 ↗ “L-PAM Melphalan, NSC-8806” NCT00002599 ↗ |
| Known as | L-Phenylalanine Mustard | “Intra-Arterial Melphalan (L-Phenylalanine Mustard) Administered in Conjunction With Osmotic Blood-Brain Barrier Disruption in Patients With Brain Malignancies: A Phase I Study” NCT00253721 ↗ |
| Known as | L-sarcolysin | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | Mel | “High-dose melphalan (MEL) with autologous stem cell transplant (SCT) is an effective therapy for systemic AL amyloidosis (AL)” NCT01527032 ↗6“combination with Fludarabine (FLU) and Melphalan (MEL) as a Preparative Regimen” NCT00800150 ↗ “Melphalan (Mel) dose, adjusted according to the patient's age:” NCT07396480 ↗ “melphalan (MEL) IV over 1 hour” NCT00550992 ↗ “* Melphalan (Mel)” NCT02988466 ↗ “Melphalan (Mel)” NCT07078721 ↗ “Melphalan (Mel)” NCT07025824 ↗ |
| Known as | Melfalan | “Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4 and Prednisone, 60 mg/m2 oral, days 1 to 4” NCT00652041 ↗4“Melfalán, 0,25 mg/Kg oral days 1 to 4 Prednisone, 1 mg/Kg oral days 1 to 4; 0,5 mg/Kg oral days 5 to 8 and 0,25 mg/Kg oral days 9 to 12.” NCT00461747 ↗ “Melfalan used outside ofcurrent indication” NCT04817956 ↗ “Busulfan and Melfalan (BUMEL)” NCT02727387 ↗ |
| Known as | Melphalan HCL | “Patients will be randomized to receive 100 mg/m2 of Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and Alkeran for Injection on Day -2 prior to ASCT.” NCT00925782 ↗2“Melphalan HCl for Injection has been approved by NMPA as a standard conditioning drug for ASCT in MM patients.” NCT06425276 ↗ “High-Dose Melphalan HCL for Injection (Propylene Glycol-Free)” NCT01660633 ↗ |
| Known as | Melphalan hydrochloride | “Drug Name: melphalan hydrochloride The dosage of different dosage groups were: 9 mg/m2; 18 mg/m2; 27 mg/m2; 40 mg/m2 Administration frequency: once for each subject” NCT05438394 ↗5“Drug: Melphalan hydrochloride” NCT01688401 ↗ “Drug: Melphalan hydrochloride” NCT01293539 ↗ “Drug: Melphalan Hydrochloride” NCT03417284 ↗ |
| Known as | Melphalan Hydrochloride for Injection | “Drug: Melphalan Hydrochloride for Injection” NCT06425276 ↗ |
| Known as | Melphalan Ideogen | “The present study aims to combine high-dose melphalan (Melphalan Ideogen) with treosulfan (Trecondi® Ideogen), a well established bifunctional alkylating agent.” NCT05636787 ↗ |
| Known as | Melphalan=Alkeran | “Melphalan (Alkeran™)” NCT02128230 ↗4“Melphalan (Alkeran®)” NCT00997386 ↗ “Melphalan - Alkeran” NCT02148913 ↗ “Melphalan (Alkeran)” NCT01877837 ↗ “Melphalan=Alkeran” NCT00516191 ↗ |
| Known as | NCI-C04853 | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | NSC-241286 | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | NSC-326231 | “NSC-326231 L-PAM Melphalan” NCT00002730 ↗ |
| Known as | NSC-614629 | “NSC-614629 L-PAM Melphalan” NCT00002630 ↗ |
| Known as | NSC-8806 | “Hyperthermic intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.” NCT00001296 ↗1“L-PAM Melphalan, NSC-8806” NCT00002599 ↗ |
| Known as | PGF-Mel | “We investigated the safety and efficacy of propylene glycol-free melphalan (PGF-Mel) during HDM/SCT in patients with AL amyloidosis (ClinicalTrials.gov identifier NCT02994784).” PMID 37607644 ↗ Aug 2023 |
| Known as | Phelinun | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | Phenylalanine mustard | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | Propylene Glycol-Free Melphalan Hydrochloride | “Propylene Glycol-Free Melphalan Hydrochloride (Evomela) administered intravenously at 70-100 mg/m2/day on Days -3 and -2 prior to autologous stem cell transplantation” NCT02994784 ↗ |
| Known as | Sarcoclorin | “Sarcoclorin” NCT02727803 ↗ |
| Known as | Sarcolycin, l- | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Known as | Sarkolysin | “Sarkolysin” NCT02727803 ↗ |
| Known as | SK 15673 | ChEMBL registry synonym — accepted as the source's own label CHEMBL852 ↗ |
| Action | Inhibit | “Drugs used in chemotherapy such as melphalan work in different ways to stop cancer cells from dividing so they stop growing or die” NCT00064337 ↗ |
| Modality | Small molecule | “Busulfan and melphalan are both traditional alkylating agents” NCT00427765 ↗ |
| Route | Other | “hyperthermic isolated hepatic perfusion (IHP) with escalating dose melphalan” NCT00001576 ↗ |