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Cycle 7 Consolidation
Cycle 7 Consolidation is a CAR-T cell therapy Small molecule drug developed by Gruppo Italiano Malattie EMatologiche dell'Adulto. It is currently in Phase 2 development for Relapsed or refractory B-cell acute lymphoblastic leukemia, Relapsed or refractory diffuse large B-cell lymphoma. Also known as: MTX + ARA-C.
This drug targets the CD19 protein on B cells to induce cell death.
Cycle 7 Consolidation is a treatment for certain types of acute myeloid leukemia, including Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, and Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1. This treatment involves administering Cytarabine, Dasatinib, and Daunorubicin Hydrochloride.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Cycle 7 Consolidation |
|---|---|
| Also known as | MTX + ARA-C |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Drug class | CAR-T cell therapy |
| Target | CD19 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
The drug works by binding to CD19 on the surface of B cells, marking them for destruction by the immune system. This leads to the depletion of cancerous B cells in the body.
Approved indications
- Relapsed or refractory B-cell acute lymphoblastic leukemia
- Relapsed or refractory diffuse large B-cell lymphoma
Common side effects
- Cytokine release syndrome
- Neutropenia
- Anemia
- Thrombocytopenia
- Infections
Key clinical trials
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML (PHASE1)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) (PHASE2)
- Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (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)
- Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2 (PHASE3)
- Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (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 |
|---|---|
| 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:
- Cycle 7 Consolidation CI brief — competitive landscape report
- Cycle 7 Consolidation updates RSS · CI watch RSS
- Gruppo Italiano Malattie EMatologiche dell'Adulto portfolio CI
Frequently asked questions about Cycle 7 Consolidation
What is Cycle 7 Consolidation?
How does Cycle 7 Consolidation work?
What is Cycle 7 Consolidation used for?
Who makes Cycle 7 Consolidation?
Is Cycle 7 Consolidation also known as anything else?
What drug class is Cycle 7 Consolidation in?
What development phase is Cycle 7 Consolidation in?
What are the side effects of Cycle 7 Consolidation?
What does Cycle 7 Consolidation target?
Related
- Drug class: All CAR-T cell therapy drugs
- Target: All drugs targeting CD19
- Manufacturer: Gruppo Italiano Malattie EMatologiche dell'Adulto — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory B-cell acute lymphoblastic leukemia
- Indication: Drugs for Relapsed or refractory diffuse large B-cell lymphoma
- Also known as: MTX + ARA-C
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing