Treats advanced or metastatic breast cancer. Sold as Tykerb. Every FDA application for this active ingredient: 1 branded and 2 generic.
As of Nov 15, 2026, FDA lists 3 applications for Lapatinib Ditosylate (sold as Tykerb), first approved Mar 13, 2007, with 4 new uses approved and 0 published complete response letters.
| Lapatinib | Part D | $6.5M | +10% | 232 |
| Tykerb | Part D | $1.8M | -36% | 31 |
| T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain MetastasisBreast Cancer With Brain Metastasis, HER2-positive Breast Cancer · Fudan University | Phase 2 | Recruiting | Sep 3, 2025 |
| Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted TherapyLocally Advanced Cancer, Metastatic Cancer · Vanderbilt-Ingram Cancer Center | Early phase 1 | Recruiting | Feb 14, 2025 |
| A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast CancerBreast Cancer · Tianjin Hemay Pharmaceutical Co., Ltd | Phase 3 | Recruiting | Mar 15, 2024 |
| Antineoplastic Drugs in Elderly PatientsCancer · Shandong University | — | Recruiting | Jul 20, 2022 |
| Implantable Microdevice In Primary Brain TumorsGrade II Glioma, Grade III Glioma · Oliver Jonas | Early phase 1 | Recruiting | Oct 23, 2019 |
| Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatmentMalignant Solid Neoplasms · Centre Leon Berard | Phase 2 | Recruiting | Jan 7, 2014 |
| Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by SurgeryMetastatic Thyroid Gland Carcinoma, Unresectable Thyroid Gland Carcinoma · National Cancer Institute (NCI) | Phase 1 | Active, not recruiting | Sep 20, 2013 |
| Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast CancerBreast Neoplasms, HER2/Neu Positive · City of Hope Medical Center | Phase 2 | Active, not recruiting | Jan 10, 2011 |
| Mar 13, 2007 | TykerbNDA 22059 · New molecular entity | Novartis | 19 | Marketed |
| Sep 29, 2020 | Lapatinib DitosylateANDA 203007 | Natco Pharma Ltd | 1 | Marketed |
| Aug 16, 2024 | Lapatinib DitosylateANDA 217968 | Teva Pharms USA Inc | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Novartis