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Lapatinib oral tablets
Lapatinib oral tablets is a Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 2 development. Also known as: Tykerb/ Tyverb, platinum - based chemotherapy, radiotherapy.
Lapatinib oral tablets are small molecule medications used to treat various conditions related to breast cancer, including metastatic breast cancer. They are indicated for use in combination with other therapies such as trastuzumab and aromatase inhibitors for HER2-positive metastatic 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). -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline 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 | 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 | Lapatinib oral tablets |
|---|---|
| Also known as | Tykerb/ Tyverb, platinum - based chemotherapy, radiotherapy |
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Molecular Profiling of Advanced Soft-tissue Sarcomas (PHASE3)
- Lapatinib Plus Trametinib in KRAS Mutant NSCLC (PHASE1, PHASE2)
- A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015) (PHASE1)
- Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2 (PHASE3)
- Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer (PHASE1, PHASE2)
- Lapatinib and Bevacizumab for Metastatic Breast Cancer (PHASE2)
- Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer (PHASE2)
- Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China (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:
- Lapatinib oral tablets CI brief — competitive landscape report
- Lapatinib oral tablets updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Lapatinib oral tablets
What is Lapatinib oral tablets?
Who makes Lapatinib oral tablets?
Is Lapatinib oral tablets also known as anything else?
What development phase is Lapatinib oral tablets in?
Related
- Manufacturer: GlaxoSmithKline — full pipeline
- Also known as: Tykerb/ Tyverb, platinum - based chemotherapy, radiotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing