Last reviewed 2026-06-03 · How we verify

Perioperative mFLOT

Sixth Affiliated Hospital, Sun Yat-sen University · Phase 3 active Small molecule Under review

Perioperative mFLOT is a Chemotherapy regimen Small molecule drug developed by Sixth Affiliated Hospital, Sun Yat-sen University. It is currently in Phase 3 development for Gastric adenocarcinoma, Esophageal adenocarcinoma, Esophageal squamous cell carcinoma.

Perioperative mFLOT is a chemotherapy regimen used to treat various types of cancer.

Perioperative mFLOT is a chemotherapy regimen being studied for the treatment of Esophagogastric Junction Disorder and Neoplasms. It is being compared to chemoradiation with weekly 5Fu and oxaliplatin, as well as Perioperative FOLFOX, in a randomized controlled trial for locally advanced EGJ adenocarcinoma.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Perioperative mFLOT
Sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Drug class	Chemotherapy regimen
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

The mFLOT regimen combines multiple chemotherapy drugs to target rapidly dividing cancer cells. This approach aims to maximize the effectiveness of treatment while minimizing side effects. The specific combination of drugs in mFLOT allows for a tailored approach to cancer treatment, taking into account the individual patient's needs and cancer type.

Approved indications

Gastric adenocarcinoma
Esophageal adenocarcinoma
Esophageal squamous cell carcinoma

Common side effects

Neutropenia
Thrombocytopenia
Anemia
Nausea and vomiting
Diarrhea

Key clinical trials

Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma (PHASE3)

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:

Perioperative mFLOT CI brief — competitive landscape report
Perioperative mFLOT updates RSS · CI watch RSS
Sixth Affiliated Hospital, Sun Yat-sen University portfolio CI

Frequently asked questions about Perioperative mFLOT

What is Perioperative mFLOT?

Perioperative mFLOT is a Chemotherapy regimen drug developed by Sixth Affiliated Hospital, Sun Yat-sen University, indicated for Gastric adenocarcinoma, Esophageal adenocarcinoma, Esophageal squamous cell carcinoma.

How does Perioperative mFLOT work?

Perioperative mFLOT is a chemotherapy regimen used to treat various types of cancer.

What is Perioperative mFLOT used for?

Perioperative mFLOT is indicated for Gastric adenocarcinoma, Esophageal adenocarcinoma, Esophageal squamous cell carcinoma.

Who makes Perioperative mFLOT?

Perioperative mFLOT is developed by Sixth Affiliated Hospital, Sun Yat-sen University (see full Sixth Affiliated Hospital, Sun Yat-sen University pipeline at /company/sixth-affiliated-hospital-sun-yat-sen-university).

What drug class is Perioperative mFLOT in?

Perioperative mFLOT belongs to the Chemotherapy regimen class. See all Chemotherapy regimen drugs at /class/chemotherapy-regimen.

What development phase is Perioperative mFLOT in?

Perioperative mFLOT is in Phase 3.

What are the side effects of Perioperative mFLOT?

Common side effects of Perioperative mFLOT include Neutropenia, Thrombocytopenia, Anemia, Nausea and vomiting, Diarrhea.

Drug class: All Chemotherapy regimen drugs
Manufacturer: Sixth Affiliated Hospital, Sun Yat-sen University — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Gastric adenocarcinoma
Indication: Drugs for Esophageal adenocarcinoma
Indication: Drugs for Esophageal squamous cell carcinoma

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing