BICNU (carmustine)
BICNU (carmustine) is a nitrosourea indicated as palliative therapy, either as a single agent or in established combination therapy, for several malignancies. Its primary indications include brain tumors (glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors), multiple myeloma (in combination with prednisone), and relapsed or refractory Hodgkin's and Non-Hodgkin's lymphomas (in combination with other approved drugs).
How BICNU Works
The mechanism of action of carmustine is not fully understood but involves the alkylation of DNA and RNA. Notably, it does not exhibit cross-resistance with other alkylating agents. Carmustine also inhibits key enzymatic processes via the carbamoylation of amino acids in proteins. Both the parent drug and its metabolites contribute to its antitumor activity and systemic toxicity.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1977-03-07
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BICNU Approval History
What BICNU Treats
9 indicationsBICNU is approved for 9 conditions since its original approval in 1977. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Brain Tumor
- Glioblastoma
- Brainstem Glioma
- Medulloblastoma
- Astrocytoma
- Ependymoma
- Multiple Myeloma
- Hodgkin's Lymphoma
BICNU Boxed Warning
MYELOSUPPRESSION and PULMONARY TOXICITY Myelosuppression Carmustine for injection, USP causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [ see Warnings and Precautions (5.1) and Adverse Reactions (6) ]. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [ see Dosage and Administration (2.1) ]. Do not administer a repeat course...
WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY Myelosuppression Carmustine for injection, USP causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [ see Warnings and Precautions (5.1) and Adverse Reactions (6) ]. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [ see Dosage and Administration (2.1) ]. Do not administer a repeat course of carmustine for injection, USP until blood counts recover. Pulmonary Toxicity Carmustine for injection, USP causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions (6) and Use in Specific Populations (8.4) ] . WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY See full prescribing information for complete boxed warning Suppression of marrow function, notably thrombocytopenia and leukopenia, is the most common and severe of the toxic effects of carmustine for injection, USP. Monitor blood counts. (5, 6). Pulmonary toxicity from carmustine for injection, USP appears to be dose related. Patients receiving greater than 1400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less (5, 6).
BICNU Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BICNU's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BICNU treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BICNU
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
48 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03382977 | VBI-1901-01 | Ph 1, Ph 2 | terminated | Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects |
| NCT04728633 | 20P.1076 JT 15505 | Ph 2 | active not recruiting | Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases |
| NCT02443077 results posted | NCI-2015-00668 NCI-2015-00668, BMT CTN 1201 | Ph 3 | active not recruiting | Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma |
| NCT05521984 | 202210013 | Ph 1 | recruiting | Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i) |
| NCT06692452 | 24-462 | Ph 2 | withdrawn | Tazemetostat Plus CHOP in 1L T-cell Lymphoma |
| NCT06687772 CNS-PHLAT | 202411136 | Ph 2 | recruiting | CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant |
| NCT06915246 | LY-201 | Ph 2 | recruiting | A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma |
| NCT00716066 | 2260.00 NCI-2010-00403, 2260.00 | Ph 2 | active not recruiting | Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases |
| NCT01511562 results posted | CALGB-51101 CALGB-51101, CDR0000721927 | Ph 2 | active not recruiting | Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma |
| NCT02896582 LyMa101 | LyMa101 | Ph 2 | completed | Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance |
| NCT04871607 | 20420 NCI-2021-03073, 20420 | Ph 2 | recruiting | Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma |
| NCT01840566 | 12-117 | Ph 1 | active not recruiting | High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma |
| NCT05052957 hSTAR GBM | CASE5320 1U01CA236215-01 | Ph 2 | recruiting | hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM) |
| NCT02329080 results posted | IELSG42 | Ph 2 | completed | New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement |
| NCT06377540 | 2022LS174 | Ph 2 | recruiting | MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma |
| NCT03583424 results posted | OSU-17225 NCI-2018-01039 | Ph 1, Ph 2 | completed | Venetoclax, Carmustine, Etoposide, Cytarabine, and Melphalan Before Stem Cell Transplant in Treating Participants With Relapsed or Refractory Non-Hodgkin Lymphoma |
| NCT02797470 results posted | AMC-097 NCI-2015-01745, 9933 | Ph 1, Ph 2 | active not recruiting | Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant |
| NCT02342782 | 14349 NCI-2015-00019, 14349 | Ph 1 | completed | Yttrium Y 90 Basiliximab and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Mature T-cell Non-Hodgkin Lymphoma |
| NCT01476839 | 08179 NCI-2011-03334, P01CA030206 | Ph 1 | completed | Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma |
| NCT04421378 results posted | XPORT-GBM-029 2021-000080-67 | Ph 1, Ph 2 | terminated | A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma |
| NCT00968760 | 2007-0635 5R01CA141303-03, NCI-2011-01129 | Ph 1 | completed | CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies |
| NCT03072771 | 201704108 | Ph 1 | completed | Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL) |
| NCT01035463 results posted | 0446-08-FB NCI-2009-01436, RV-LYM-PI-0328 | Ph 1, Ph 2 | completed | Lenalidomide Therapy After Chemotherapy & Stem Cell Transplant in Treating Chemotherapy Resistan Non-Hodgkin Lymphoma |
| NCT03019640 results posted | 2015-0751 NCI-2018-01239, 2015-0751 | Ph 2 | completed | Umbilical Cord Blood NK Cells, Rituximab, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma |
| NCT05228249 | RG1121551 NCI-2021-14126, 10881 | Ph 1 | withdrawn | Loncastuximab Tesirine in Combination With Chemotherapy Prior to Stem Cell Transplant for the Treatment of Recurrent or Refractory Diffuse Large B-Cell Lymphoma |
| NCT00669669 results posted | 2000.00 NCI-2013-00701, 8357 | Ph 1, Ph 2 | terminated | O6-Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cell in Treating Patients With Malignant Gliomas |
| NCT02059239 results posted | 1208012875 | Ph 1, Ph 2 | completed | Bendamustine Bridge to Autologous or Allogeneic Transplant for Relapsed/Refractory Lymphoma |
| NCT02483000 results posted | 9189 NCI-2015-00299, 9189 | Ph 1 | terminated | Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies |
| NCT02504359 | IRB00011097 NCI-2015-01065, HEM-14099-LM | Ph 1 | completed | Combination Chemotherapy and Donor Stem Cell Transplant Followed by Ixazomib Citrate Maintenance Therapy in Treating Patients With Relapsed High-Risk Multiple Myeloma |
| NCT01921387 results posted | 2728.00 NCI-2013-01378, 2728.00 | Ph 1, Ph 2 | completed | Radiolabeled Monoclonal Antibody and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With High-Risk Lymphoid Malignancies |
| NCT00795665 results posted | 224865 UCDCC#208, P30CA093373 | Ph 2 | completed | Bevacizumab and Carmustine in Treating Patients With Relapsed or Progressive High-Grade Glioma |
| NCT00632827 results posted | 072518 NCI-2011-01285 | Ph 2 | terminated | Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak) |
| NCT00992446 results posted | 2292.00 NCI-2009-01302, FH 2292/X05287 | Ph 2 | completed | Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma |
| NCT03579927 | 2017-0295 NCI-2018-01111, 2017-0295 | Ph 1, Ph 2 | withdrawn | CAR.CD19-CD28-zeta-2A-iCasp9-IL15-Transduced Cord Blood NK Cells, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Participants With B-cell Lymphoma |
| NCT01008462 results posted | 2241.00 NCI-2009-01334, 2241.00 | Ph 2 | completed | Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia |
| NCT02343666 | 2673.00 NCI-2014-02395, 2673 | Ph 1 | withdrawn | HIV-Resistant Gene Modified Stem Cells and Chemotherapy in Treating Patients With Lymphoma With HIV Infection |
| NCT00695409 results posted | 07076 P01CA030206, P30CA033572 | Ph 2 | completed | Yttrium-90 Ibritumomab Tiuxetan Plus High-Dose BEAM Followed By ASCT For Relapsed B-Cell Non-Hodgkin Lymphoma |
| NCT00961220 results posted | NCI-2012-02927 NCI-2012-02927, 3405 | Ph 1, Ph 2 | completed | O6-Benzylguanine and Topical Carmustine in Treating Patients With Early-Stage IA-IIA Cutaneous T-Cell Lymphoma |
| NCT01692691 results posted | 12-10 | Ph 2 | terminated | Dacarbazine and Carmustine in Metastatic Melanoma |
| NCT02366663 SPINOZA results posted | 12338 NCI-2015-00185 | Ph 3 | terminated | BEAM vs. 90-Yttrium Ibritumomab Tiuxetan (Zevalin®)/BEAM With ASCT for Relapsed DLBCL |
| NCT01969435 results posted | 201312115 | Ph 2 | completed | Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma |
| NCT02348255 | UCDCC#249 663113, UCDCC#249 | Ph 2 | withdrawn | NovoTTF-100A With Bevacizumab and Carmustine in Treating Patients With Glioblastoma Multiforme in First Relapse |
| NCT00691015 results posted | 2007-127 P30CA022453, GENZ-WSU-2007-127 | Ph 2 | completed | Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant |
| NCT00920153 | LH 2007 | Ph 3 | terminated | Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma |
| NCT00723658 | S0629 S0629, U10CA032102 | Ph 2 | withdrawn | S0629, Observation or Combination Chemotherapy, Bortezomib, Thalidomide, and Rituximab Followed By Two Autologous Peripheral Blood Stem Cell Transplants in Treating Patients With Waldenstrom Macroglobulinemia |
| NCT00761280 SAPPHIRE results posted | AP 12009-G005 | Ph 3 | terminated | Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma |
| NCT01653418 V-BEAM results posted | 201208046 | Ph 2 | terminated | Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation |
| NCT01500161 | 1127920 | Ph 2 | terminated | Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BICNU FDA Label Details
Indications & Usage
FDA Label (PDF)BICNU is indicated for the treatment of Brain Tumor; Glioblastoma; Brainstem Glioma; Medulloblastoma; Astrocytoma; Ependymoma; Multiple Myeloma; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma.
WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY Myelosuppression Carmustine for injection, USP causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [ see Warnings and Precautions (5.1) and Adverse Reactions ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment