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FLOT chemotherapy
FLOT chemotherapy is a Combination chemotherapy regimen Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Gastric and gastroesophageal junction adenocarcinoma, Metastatic gastric cancer. Also known as: FLOT.
FLOT is a combination chemotherapy regimen that uses four cytotoxic agents to inhibit cancer cell division and induce apoptosis.
FLOT is a combination chemotherapy regimen that uses four cytotoxic agents to inhibit cancer cell division and induce apoptosis. Used for Gastric and gastroesophageal junction adenocarcinoma, Metastatic gastric cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | FLOT chemotherapy |
|---|---|
| Also known as | FLOT |
| Sponsor | AstraZeneca |
| Drug class | Combination chemotherapy regimen |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FLOT combines fluorouracil (5-FU), leucovorin, oxaliplatin, and docetaxel to attack cancer cells through multiple mechanisms: 5-FU inhibits thymidylate synthase and incorporates into RNA/DNA; oxaliplatin creates DNA cross-links; and docetaxel stabilizes microtubules to prevent cell division. The combination provides synergistic cytotoxic effects across different phases of the cell cycle.
Approved indications
- Gastric and gastroesophageal junction adenocarcinoma
- Metastatic gastric cancer
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Nausea and vomiting
- Diarrhea
- Peripheral neuropathy
- Fatigue
- Mucositis
Key clinical trials
- Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity (PHASE2, PHASE3)
- A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (PHASE2)
- Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) (PHASE1)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) (PHASE3)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Extension (PHASE3)
- Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations (PHASE2, PHASE3)
- Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma (PHASE2)
- A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer (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:
- FLOT chemotherapy CI brief — competitive landscape report
- FLOT chemotherapy updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about FLOT chemotherapy
What is FLOT chemotherapy?
How does FLOT chemotherapy work?
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Who makes FLOT chemotherapy?
Is FLOT chemotherapy also known as anything else?
What drug class is FLOT chemotherapy in?
What development phase is FLOT chemotherapy in?
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Related
- Drug class: All Combination chemotherapy regimen drugs
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Gastric and gastroesophageal junction adenocarcinoma
- Indication: Drugs for Metastatic gastric cancer
- Also known as: FLOT
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing