Last reviewed · How we verify
Melflufen
At a glance
| Generic name | Melflufen |
|---|---|
| Also known as | Melphalan Flufenamide, Pepaxto, Pepaxti, Melphalan flufenamide |
| Sponsor | Oncopeptides AB |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | discontinued |
Approved indications
- Relapsed or refractory multiple myeloma
Common side effects
Key clinical trials
- Melflufen for Elderly Myeloma Patients in Second or Subsequent Relapse (Phase 2)
- A Randomized, Two-period, Cross-over, Phase 2 Study, Comparing Pharmacokinetics, and Assessing Safety and Tolerability of Peripheral and Central i.v. Administration of Melphalan Flufenamide (Melflufen (Phase 2)
- A Randomized, Controlled, Open-Label Phase 3 Study of Melflufen in Combination With Daratumumab Compared With Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma (Phase 3)
- A Single Arm, Open-Label, Phase 2 Study of Melflufen in Combination With Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Pomalidomide and/or an Anti-CD38 Mono (Phase 2)
- An Open-Label Phase I/IIa Study of the Safety and Efficacy of Melphalan-flufenamide (Melflufen) and Dexamethasone Combination for Patients With Relapsed and/or Relapsed-Refractory Multiple Myeloma (Phase 1)
- An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of Therapy (Phase 1)
- A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Len (Phase 3)
- An Expanded Access Program Protocol for Melphalan Flufenamide in Combination With Dexamethasone in Patients With Triple Class Refractory Multiple Myeloma (N/A)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Melflufen CI brief — competitive landscape report
- Melflufen updates RSS · CI watch RSS
- Oncopeptides AB portfolio CI