AVOPEF (etoposide)
AVOPEF is a cancer medication used for adults with refractory testicular cancer or small cell lung cancer. When used for small cell lung cancer, it serves as a first-line option in combination with chemotherapy and immunotherapy. For patients with testicular cancer, it helps those whose disease has not responded to other treatments. It is typically prescribed as part of a multi-drug regimen to target these specific tumor types.
How AVOPEF Works
This drug works by interacting with DNA-topoisomerase II or forming free radicals to cause breaks in DNA strands. These breaks lead to cell cycle arrest, primarily during the G2 stage, which prevents cancer cells from dividing. This process ultimately results in cell death, helping to control the progression of the disease.
Details
- Status
- Prescription
- First Approved
- 2026-02-13
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
AVOPEF Approval History
What AVOPEF Treats
2 indicationsAVOPEF is approved for 2 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Testicular Cancer
- Small Cell Lung Cancer
AVOPEF Boxed Warning
SEVERE MYELOSUPPRESSION AVOPEF can cause severe myelosuppression resulting in infection or bleeding [see Warnings and Precautions (5.1) ] . Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 [see Warnings and Precautions (5.1) ] . Monitor complete blood cell counts, prior to the administration of AVOPEF and before each subsequent cycle, and at appropriate intervals during and after therapy [see Warnings and Pr...
WARNING: SEVERE MYELOSUPPRESSION AVOPEF can cause severe myelosuppression resulting in infection or bleeding [see Warnings and Precautions (5.1) ] . Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 [see Warnings and Precautions (5.1) ] . Monitor complete blood cell counts, prior to the administration of AVOPEF and before each subsequent cycle, and at appropriate intervals during and after therapy [see Warnings and Precautions (5.1) ] . WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . AVOPEF can cause severe myelosuppression resulting in infection or bleeding. ( 5.1 ) Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 . ( 5.1 ) Monitor complete blood cell counts, prior to the administration of AVOPEF and before each subsequent cycle, and at appropriate intervals during and after therapy. ( 5.1 )
AVOPEF Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 AVOPEF's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AVOPEF treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AVOPEF
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
500 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06406465 | 10001601 001601-C | Ph 2 | recruiting | A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity |
| NCT06172296 | NCI-2023-08530 NCI-2023-08530, ANBL2131 | Ph 3 | recruiting | Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma |
| NCT06528691 | GLOBOTRK NCI-2024-02977 | Ph 2 | recruiting | Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors |
| NCT04301076 | NCI-2020-01535 NCI-2020-01535, 10335 | Ph 1 | suspended | Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL) |
| NCT05675410 | NCI-2022-10845 NCI-2022-10845, AHOD2131 | Ph 3 | recruiting | A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab |
| NCT03017326 PHITT | RG_15-114 | Ph 3 | active not recruiting | Paediatric Hepatic International Tumour Trial |
| NCT05019716 | NCI-2021-08926 NCI-2021-08926, 10507 | Ph 1, Ph 2 | recruiting | Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma |
| NCT07583511 | TNBG-IIT001 | Ph 2 | recruiting | Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study |
| NCT07583550 | 2026 049 A | Ph 2 | not yet recruiting | Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy, and Then Sequential Maintenance Therapy With Adebrelimab for Extensive-stage Small Cell Lung Cancer |
| NCT07155174 SEZanne | M24-633 2024-517490-24 | Ph 2 | recruiting | A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer |
| NCT03984448 | NCI-2019-03711 NCI-2019-03711, A051701 | Ph 2, Ph 3 | active not recruiting | Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas |
| NCT05058651 | NCI-2021-09851 NCI-2021-09851, S2012 | Ph 2, Ph 3 | recruiting | Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung |
| NCT06738368 | RG1124788 NCI-2024-09417, FHIRB0020869 | Ph 2 | recruiting | Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia |
| NCT06077500 DAREONᵀᴹ-8 | 1438-0008 | Ph 1 | active not recruiting | DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer |
| NCT07472517 | 1438-0012 2025-520565-51-00, U1111-1317-4955 | Ph 3 | recruiting | DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy |
| NCT06132113 | 1438-0007 U1111-1292-1400, 2023-505870-13-00 | Ph 1 | recruiting | DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers |
| NCT06646276 | CA245-0001 | Ph 3 | recruiting | A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). |
| NCT06230224 OLYMPIA-4 | R1979-HM-2299 2022-502783-21-00 | Ph 3 | active not recruiting | A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma |
| NCT05453500 | RG1122464 NCI-2022-05225, 11008 | Ph 2 | active not recruiting | Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia |
| NCT00871013 | 108053 | Ph 2 | active not recruiting | Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy |
| NCT04804007 | CTO-IUSCCC-0742 | Ph 2 | recruiting | Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT |
| NCT07227597 | 6070-003 MK-6070-003, U1111-1318-5025 | Ph 1, Ph 2 | recruiting | A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003) |
| NCT04803201 | A051902 NCI-2021-01380, U10CA180821 | Ph 2 | suspended | Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma |
| NCT01920932 results posted | HLHR13 NCI-2013-01123 | Ph 2 | active not recruiting | Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma |
| NCT07544654 | 1438-0011 2025-523869-22, U1111-1328-6623 | Ph 3 | not yet recruiting | DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy |
| NCT06401330 | AREN2231 NCI-2024-03424, AREN2231 | Ph 3 | recruiting | A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT) |
| NCT04293562 | AAML1831 NCI-2020-00546, AAML1831 | Ph 3 | recruiting | A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations |
| NCT04322318 | AREN1921 NCI-2020-01561, AREN1921 | Ph 2 | recruiting | A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT |
| NCT03067181 | AGCT1531 NCI-2017-00178, AGCT1531 | Ph 3 | recruiting | Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors |
| NCT03182244 results posted | 2215-CL-0303 CTR20170326 | Ph 3 | active not recruiting | A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation |
| NCT06217757 | SCS-Lung01 | Ph 1, Ph 2 | recruiting | Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC |
| NCT04684368 | ACNS2021 NCI-2020-13175, ACNS2021 | Ph 2 | recruiting | A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT |
| NCT07005128 DeLLphi-312 | 20240178 | Ph 3 | recruiting | A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) |
| NCT02176967 | ANBL1232 NCI-2014-00677, s15-00462 | Ph 3 | active not recruiting | Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma |
| NCT05533775 iMATRIX GLO | CO43810 | Ph 1, Ph 2 | recruiting | A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma |
| NCT05815160 | Debio 0123-SCLC-104 2024-510980-40-00, U1111-1302-8787 | Ph 1 | terminated | Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy |
| NCT02166463 results posted | NCI-2014-01223 NCI-2014-01223, s15-00950 | Ph 3 | active not recruiting | Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma |
| NCT02112916 results posted | NCI-2014-00712 NCI-2014-00712, s14-01925 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma |
| NCT02101853 results posted | NCI-2014-00631 NCI-2014-00631, s15-00970 | Ph 3 | active not recruiting | Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia |
| NCT02883049 results posted | NCI-2011-03797 NCI-2011-03797, S12-01254 | Ph 3 | active not recruiting | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations |
| NCT06368817 | ACNS2321 NCI-2024-03518, ACNS2321 | Ph 2 | recruiting | A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma |
| 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 |
| NCT03007147 | AALL1631 NCI-2016-01588, AALL1631 | Ph 3 | active not recruiting | Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
| NCT05624996 | NRG-LU008 NCI-2022-08263, NRG-LU008 | Ph 3 | recruiting | Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer |
| NCT02595424 results posted | EA2142 NCI-2015-00547, EA2142 | Ph 2 | active not recruiting | Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas |
| NCT02003222 results posted | NCI-2013-02229 NCI-2013-02229, ECOG-E1910 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia |
| NCT04092283 | NCI-2019-06124 NCI-2019-06124, EA5181 | Ph 3 | active not recruiting | Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer |
| NCT03811002 results posted | NCI-2019-00178 NCI-2019-00178, NRG-LU005 | Ph 3 | active not recruiting | Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC) |
| NCT01096368 results posted | ACNS0831 NCI-2011-02029, 10-01676 | Ph 3 | completed | Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma |
| NCT03206671 B-NHL 2013 | UKM12_0020 2013-003253-21 | Ph 3 | active not recruiting | Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents |
Showing 50 of 500 trials
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.
AVOPEF FDA Label Details
Indications & Usage
FDA Label (PDF)AVOPEF is indicated for the treatment of Testicular Cancer; Small Cell Lung Cancer.
WARNING: SEVERE MYELOSUPPRESSION AVOPEF can cause severe myelosuppression resulting in infection or bleeding [see Warnings and Precautions (5.1) ] . Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 [see Warnings...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.