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Proleukin (ALDESLEUKIN)
Proleukin (Aldesleukin) is a lymphocyte growth factor that targets the interleukin-2 receptor. It is a small molecule modality that was originally developed by Chiron and is currently owned by the same company. Proleukin was FDA-approved in 1992 for the treatment of metastatic malignant melanoma, metastatic renal cell carcinoma, and acute myeloid leukemia. The commercial status of Proleukin is patented, and it is not yet available as a generic. Key safety considerations include potential severe side effects such as flu-like symptoms, rash, and cardiovascular issues.
At a glance
| Generic name | ALDESLEUKIN |
|---|---|
| Sponsor | Chiron |
| Drug class | Lymphocyte Growth Factor [EPC] |
| Target | Interleukin-2 receptor |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1992 |
Approved indications
- Acute myeloid leukemia, disease
- Metastatic malignant melanoma
- Metastatic renal cell carcinoma
Common side effects
- Hypotension
- Hyperbilirubinemia
- Dyspnea
- Rash
- Diarrhea
- Oliguria
- Chills
- Vomiting
- Thrombocytopenia
- Nausea
- Confusional state
- Increased creatinine
Serious adverse events
- Fatal adverse reactions
- Fatal adverse reactions
- Cardiac arrest
- Myocardial infarction
- Pulmonary embolism
- Cerebrovascular accident
- Hepatic failure
- Renal failure
- Pulmonary edema
- Respiratory failure
Key clinical trials
- Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer (PHASE1,PHASE2)
- Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers (PHASE1,PHASE2)
- A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab (PHASE2)
- Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies (PHASE1)
- T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer (PHASE2)
- Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer (PHASE2)
- Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma (PHASE2)
- Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients (PHASE1,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:
- Proleukin CI brief — competitive landscape report
- Proleukin updates RSS · CI watch RSS
- Chiron portfolio CI