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FEC-Doc adjuvant chemotherapy
FEC-Doc adjuvant chemotherapy is a Combination chemotherapy (anthracycline + taxane) Small molecule drug developed by Ludwig-Maximilians - University of Munich. It is currently in Phase 3 development for Adjuvant treatment of early-stage breast cancer (Phase 3 trial context).
FEC-Doc is a combination chemotherapy regimen that uses fluorouracil, epirubicin, and cyclophosphamide followed by docetaxel to kill rapidly dividing cancer cells and prevent recurrence.
FEC-Doc is a combination chemotherapy regimen that uses fluorouracil, epirubicin, and cyclophosphamide followed by docetaxel to kill rapidly dividing cancer cells and prevent recurrence. Used for Adjuvant treatment of early-stage breast cancer (Phase 3 trial context).
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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.
| 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 | FEC-Doc adjuvant chemotherapy |
|---|---|
| Sponsor | Ludwig-Maximilians - University of Munich |
| Drug class | Combination chemotherapy (anthracycline + taxane) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FEC (fluorouracil, epirubicin, cyclophosphamide) is a standard anthracycline-based chemotherapy combination that damages DNA in cancer cells. Docetaxel (Doc), a taxane, is added sequentially to further inhibit microtubule function and enhance cytotoxic effects. This adjuvant approach targets residual micrometastatic disease after surgery to improve disease-free and overall survival.
Approved indications
- Adjuvant treatment of early-stage breast cancer (Phase 3 trial context)
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Nausea and vomiting
- Alopecia
- Mucositis
- Cardiotoxicity
- Peripheral neuropathy
Key clinical trials
- Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (PHASE3)
- Combination Chemotherapy in Treating Women With Breast Cancer (PHASE3)
- Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer (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:
- FEC-Doc adjuvant chemotherapy CI brief — competitive landscape report
- FEC-Doc adjuvant chemotherapy updates RSS · CI watch RSS
- Ludwig-Maximilians - University of Munich portfolio CI
Frequently asked questions about FEC-Doc adjuvant chemotherapy
What is FEC-Doc adjuvant chemotherapy?
How does FEC-Doc adjuvant chemotherapy work?
What is FEC-Doc adjuvant chemotherapy used for?
Who makes FEC-Doc adjuvant chemotherapy?
What drug class is FEC-Doc adjuvant chemotherapy in?
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Related
- Drug class: All Combination chemotherapy (anthracycline + taxane) drugs
- Manufacturer: Ludwig-Maximilians - University of Munich — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Adjuvant treatment of early-stage breast cancer (Phase 3 trial context)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing