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Chemotherapy for hematologic malignancy
Chemotherapy for hematologic malignancy is a Small molecule drug developed by M.D. Anderson Cancer Center. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Chemotherapy for hematologic malignancy |
|---|---|
| Sponsor | M.D. Anderson Cancer Center |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Injection site erythema
- Injection site pain
- Injection site swelling
- Pyrexia
- Diarrhoea
- Nausea
- Fatigue
- Neutropenia
- Anaemia
- Stomatitis
- Headache
- Cough
Key clinical trials
- A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML (PHASE1)
- Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies (NA)
- Venetoclax Basket Trial for High Risk Hematologic Malignancies (PHASE1)
- Reduction of Hematologic Toxicity in Locally Advanced Cervical Cancers (NA)
- Daratumumab in VHR T-ALL Treated According to the ALL National Treatment Program (PHASE2)
- Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant (PHASE1)
- Detecting HPV DNA in Anal and Cervical Cancers
- Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Aggressive T Cell Hematological Malignancies (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:
- Chemotherapy for hematologic malignancy CI brief — competitive landscape report
- Chemotherapy for hematologic malignancy updates RSS · CI watch RSS
- M.D. Anderson Cancer Center portfolio CI
Frequently asked questions about Chemotherapy for hematologic malignancy
What is Chemotherapy for hematologic malignancy?
Who makes Chemotherapy for hematologic malignancy?
What development phase is Chemotherapy for hematologic malignancy in?
What are the side effects of Chemotherapy for hematologic malignancy?
Related
- Manufacturer: M.D. Anderson Cancer Center — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing