Last reviewed · How we verify
Tykerb
At a glance
| Generic name | Tykerb |
|---|---|
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: HEPATOTOXICITY Hepatotoxicity has been observed in clinical trials and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain [see Warnings and Precautions (5.2)] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity has been observed in clinical trials and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths
Common side effects
- Diarrhea
- Palmar-plantar erythrodysesthesia
- Nausea
- Rash
- Vomiting
- Mucosal inflammation
- Stomatitis
- Pain in extremity
- Dyspnea
- Back pain
- Dyspepsia
- Dry skin
Serious adverse events
- Diarrhea (Grade 3-4)
- Palmar-plantar erythrodysesthesia (Grade 3-4)
- Dyspnea (Grade 3)
- Nausea (Grade 3)
- Rash (Grade 3)
- Vomiting (Grade 3)
- Back pain (Grade 3)
- Pain in extremity (Grade 3)
Key clinical trials
- Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery (PHASE2)
- DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] (PHASE3)
- Effectiveness, Safety, and Tolerability of Anti-HER2 Drugs as Targeted Therapy for Egyptian Patients With ERBB2-Positive Breast Cancer
- Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy (EARLY_PHASE1)
- HKI-272 for HER2-Positive Breast Cancer and Brain Metastases (PHASE2)
- Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer (NA)
- Molecular Profiling of Advanced Soft-tissue Sarcomas (PHASE3)
- A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer (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:
- Tykerb CI brief — competitive landscape report
- Tykerb updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI