Tykerb

Treats advanced or metastatic breast cancer. NDA 22059, held by Novartis. Lapatinib Ditosylate.

As of Nov 14, 2026, NDA 22059 (Tykerb), held by Novartis, was first approved by FDA on Mar 13, 2007, with 19 approved supplements and 0 published complete response letters.

First approved: Mar 13, 2007
Review: Priority
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TYKERB is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Dec 6, 2018	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 18, 2013	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 18, 2013	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 29, 2010	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 13, 2007	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
TykerbEQ 250MG BASE · tablet;oral	Lapatinib Ditosylate	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Mar 27, 2022	Supplement 31Labeling · Standard review	Approved	Label Letter
Dec 6, 2018	Supplement 24Labeling · Standard review	Approved	Label Letter
Dec 6, 2018	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 6, 2017	Supplement 22Labeling · Standard review	Approved	Letter Label
Mar 31, 2015	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 22, 2014	Supplement 21Labeling	Approved	Label Letter
Oct 18, 2013	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 18, 2013	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 21, 2013	Supplement 18Labeling · Standard review	Approved	Label Letter
Jun 21, 2013	Supplement 15Labeling · Standard review	Approved	Label Letter
Mar 2, 2012	Supplement 13Labeling	Approved	Letter Label
Aug 12, 2011	Supplement 12Labeling	Approved	Letter Label
Aug 12, 2011	Supplement 11Labeling	Approved	Letter Label
Jan 29, 2010	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jan 29, 2010	Supplement 6Labeling · Standard review	Approved	Letter Label
Jan 29, 2010	Supplement 3Labeling · Standard review	Approved	Letter Label
Jul 7, 2008	Supplement 4Labeling · Standard review	Approved	Letter Label
Aug 20, 2007	Supplement 2Labeling · Standard review	Approved	Letter Label
Apr 27, 2007	Supplement 1Labeling · Standard review	Approved	Letter Label
Mar 13, 2007	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 22059
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters