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Gemcitabine Lapatinib
Gemcitabine Lapatinib is a Small molecule drug developed by Latin American Cooperative Oncology Group. It is currently in Phase 2 development.
Gemcitabine is a small molecule used in combination with lapatinib, a medication for treating metastatic breast cancer. Lapatinib is a small molecule that targets various cancer-related pathways, and it is used in combination with gemcitabine and other chemotherapies for treating breast cancer.
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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).
| 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 | Gemcitabine Lapatinib |
|---|---|
| Sponsor | Latin American Cooperative Oncology Group |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia (NA)
- BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer (PHASE1)
- Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma (PHASE2)
- A Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema (PHASE1)
- Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents (PHASE1)
- Lapatinib, Cisplatin, Gemcitabine as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Urothelial Cancer (PHASE1)
- Chemotherapeutic Agents in Brain/Breast
- Safety Study in Subjects With Metastatic Breast Cancer Who Progressed After Taxanes Treatment. (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:
- Gemcitabine Lapatinib CI brief — competitive landscape report
- Gemcitabine Lapatinib updates RSS · CI watch RSS
- Latin American Cooperative Oncology Group portfolio CI
Frequently asked questions about Gemcitabine Lapatinib
What is Gemcitabine Lapatinib?
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What development phase is Gemcitabine Lapatinib in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing