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Alkeran (melphalan)
Alkeran (melphalan) is a small molecule alkylating drug originally developed by GlaxoSmithKline and currently owned by Apotex. It was first approved by the FDA in 1964 for the treatment of malignant ovarian tumors and multiple myeloma. As an off-patent medication, Alkeran is available as a generic product. Key safety considerations include its short half-life of 1 hour and moderate bioavailability of 71%. Alkeran is used to treat certain types of cancer.
At a glance
| Generic name | melphalan |
|---|---|
| Sponsor | Apotex |
| Drug class | Alkylating Drug |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1964 |
Approved indications
- Malignant tumor of ovary
- Multiple myeloma
Boxed warnings
- WARNING Melphalan should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) to oral melphalan have shown more myelosuppression with the IV formulation. Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation. Melphalan is leukemogenic in humans. Melphalan produces chromosomal aberrations in vitro and in viv o and, therefore, should be considered potentially mutagenic in humans.
Common side effects
- Bone marrow suppression
- Leukopenia
- Thrombocytopenia
- Anemia
- Hepatitis
- Jaundice
- Pulmonary fibrosis
- Interstitial pneumonitis
- Vasculitis
- Cardiac arrest
- Nausea
- Vomiting
Key clinical trials
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (PHASE3)
- Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell) Transplant and as Maintenance Therapy After Transplant in Patients With Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (PHASE2)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus Papilloma and Choroid Plexus Carcinoma Prior to Second-Look Surgery (PHASE1)
- Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases (PHASE1,PHASE2)
- Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (PHASE1,PHASE2)
- Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older (PHASE2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Alkeran CI brief — competitive landscape report
- Alkeran updates RSS · CI watch RSS
- Apotex portfolio CI