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Letrozole, Lapatinib
Letrozole, Lapatinib is a Small molecule drug developed by Asan Medical Center. It is currently in Phase 2 development. Also known as: Femara, Tykerb.
Letrozole is a small molecule inhibitor of the cytochrome P450 19A1 enzyme, which is involved in the production of estrogen. It is used in combination with other treatments, such as Lapatinib, to treat metastatic breast cancer, including HER2-negative and HER2-positive cases.
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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 | Letrozole, Lapatinib |
|---|---|
| Also known as | Femara, Tykerb |
| Sponsor | Asan Medical Center |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer (PHASE2)
- Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy (PHASE2)
- A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer (PHASE3)
- DETECT III - A Multicenter, Phase III Study to Compare Standard Therapy +/- Lapatinib in HER2-ve MBC-Patients With HER2+ve CTCs (PHASE3)
- Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer (PHASE1)
- Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer (PHASE2)
- Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer (PHASE2)
- Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic 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:
- Letrozole, Lapatinib CI brief — competitive landscape report
- Letrozole, Lapatinib updates RSS · CI watch RSS
- Asan Medical Center portfolio CI
Frequently asked questions about Letrozole, Lapatinib
What is Letrozole, Lapatinib?
Who makes Letrozole, Lapatinib?
Is Letrozole, Lapatinib also known as anything else?
What development phase is Letrozole, Lapatinib in?
Related
- Manufacturer: Asan Medical Center — full pipeline
- Also known as: Femara, Tykerb
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing