CLINICAL TRIALS PROFILE FOR TYKERB

505(b)(2) Clinical Trials for TYKERB

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00496366 ↗	Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	2007-07-23	Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types. The purpose of this research study is to compare an approved treatment for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered "investigational", which means the drug has not been approved by the US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However, this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine may help stop cancer cells as well as or better than capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue to receive these medications unless they experience severe, serious and/or excessive side effects, the cancer becomes worse, the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatment.Tests and procedures such as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.
OTC	NCT00496366 ↗	Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer	Terminated	Rutgers Cancer Institute of New Jersey	Phase 2	2007-07-23	Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types. The purpose of this research study is to compare an approved treatment for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered "investigational", which means the drug has not been approved by the US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However, this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine may help stop cancer cells as well as or better than capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue to receive these medications unless they experience severe, serious and/or excessive side effects, the cancer becomes worse, the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatment.Tests and procedures such as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.
OTC	NCT00496366 ↗	Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer	Terminated	Rutgers, The State University of New Jersey	Phase 2	2007-07-23	Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types. The purpose of this research study is to compare an approved treatment for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered "investigational", which means the drug has not been approved by the US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However, this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine may help stop cancer cells as well as or better than capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue to receive these medications unless they experience severe, serious and/or excessive side effects, the cancer becomes worse, the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatment.Tests and procedures such as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.

All Clinical Trials for TYKERB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00095563 ↗	Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers	Completed	National Cancer Institute (NCI)	Phase 2	2004-09-01	Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
NCT00095667 ↗	Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2004-11-01	Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent or metastatic prostate cancer.
NCT00095940 ↗	Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2004-10-01	This phase I/II trial studies lapatinib to see how well it works in treating young patients with recurrent or refractory central nervous system (CNS) tumors. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

Clinical Trial Conditions for TYKERB

Condition Name

Condition Name for TYKERB
Intervention	Trials
Breast Cancer	21
Stage IV Breast Cancer	11
Metastatic Breast Cancer	10

Condition MeSH

Condition MeSH for TYKERB
Intervention	Trials
Breast Neoplasms	58
Carcinoma	15
Neoplasm Metastasis	8

Clinical Trial Locations for TYKERB

Trials by Country

Trials by Country for TYKERB
Location	Trials
United States	452
Germany	37
Canada	30
Italy	28
Spain	23

Trials by US State

Trials by US State for TYKERB
Location	Trials
Texas	27
California	25
Tennessee	18
Ohio	17
Pennsylvania	17

Clinical Trial Progress for TYKERB

Clinical Trial Phase

Clinical Trial Phase for TYKERB
Clinical Trial Phase	Trials
Phase 3	7
Phase 2/Phase 3	1
Phase 2	51

Clinical Trial Status

Clinical Trial Status for TYKERB
Clinical Trial Phase	Trials
Completed	63
Terminated	17
Active, not recruiting	11

Clinical Trial Sponsors for TYKERB

Sponsor Name

Sponsor Name for TYKERB
Sponsor	Trials
GlaxoSmithKline	37
National Cancer Institute (NCI)	32
Novartis	11

Sponsor Type

Sponsor Type for TYKERB
Sponsor	Trials
Other	90
Industry	63
NIH	32

Last updated: May 6, 2026

TYKERB (lapatinib): Clinical Trials Update and Market Outlook

What is TYKERB and how is it positioned in oncology?

TYKERB is the brand name for lapatinib, an oral tyrosine kinase inhibitor targeting EGFR (ERBB1) and HER2 (ERBB2). Clinically, TYKERB is used in HER2-positive breast cancer, primarily in combination regimens, with its most established role in later-line settings where HER2 remains a driver.

Across historical development and commercial life, TYKERB’s commercial footprint has centered on HER2-positive disease and combination use with standard systemic therapy (notably capecitabine in advanced settings), with label scope evolving over time.

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What is the current clinical-trials status for TYKERB?

No complete, single source in the provided information set supports a fresh, verifiable “current enrollment and active sites” update for TYKERB across registries. The requirement to produce a complete and accurate trials update cannot be met from the available context.

Because a trials update must be accurate by trial phase, status, and dates, the analysis below uses only what is solidly supported at the level of TYKERB’s commercial life cycle: it is an established, long-available HER2 TKI and not a current launch-cycle asset.

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How has TYKERB’s market trajectory changed over time?

TYKERB is a legacy oncology product facing long-term competitive pressure from newer HER2-targeted regimens, including antibody-drug conjugates and TKIs with broader modern sequencing advantages.

Market dynamics for TYKERB historically followed a pattern common to HER2 small-molecule TKIs:

• Peak adoption driven by label fit in HER2-positive metastatic disease and combination use
• Erosion as HER2 treatment algorithms moved toward therapies that show stronger outcomes in modern lines, including ADCs and regimen reshuffling after randomized data
• Concentration into specific patient niches where clinician preference and payer coverage align with existing evidence and combination tolerability

This erosion is consistent with how HER2 therapy has reorganized around newer mechanisms of action and higher efficacy in pivotal trials over subsequent product generations.

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What is the competitive landscape TYKERB faces?

TYKERB competes within HER2-positive oncology across multiple decision points: first-line progression, second-line after trastuzumab-based therapy, and post-ADC or post-TKI sequencing. Competitive pressure comes from:

• HER2 monoclonal antibodies
• Antibody-drug conjugates (ADCs)
• Newer small-molecule HER2 TKIs with label and regimen advantages in modern treatment pathways

In practice, TKIs like lapatinib sustain use where:

• Patients have already received multiple HER2 regimens and remain EGFR/HER2-driven biology
• Combination tolerability fits capecitabine-based approaches
• Real-world sequencing and reimbursement keep lapatinib in active formularies

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What market projections are realistic for TYKERB?

A complete projection with forecasted sales requires current-year revenue anchors and region-specific payer and guideline assumptions. The provided information set does not include TYKERB’s latest revenue base year, recent unit or prescription trends, or registry-backed patient utilization proxies.

Given TYKERB’s legacy status and the sustained HER2 regimen shift toward newer therapies, the market outlook is structurally constrained:

• Low to mid single-digit decline is the typical trajectory for legacy oncology brands as indications narrow, sequencing shifts, and competitive displacement continues.
• Stabilization can occur where the remaining label supports a durable niche and generic competition does not erase price more than demand.

Without the required baseline sales and utilization series, no defensible numeric forecast can be produced without risking inaccuracy.

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Where does TYKERB still hold clinical and payer value?

TYKERB’s value proposition persists mainly through:

• Combination therapy roles in HER2-positive advanced settings where it remains an accepted option
• Oral administration and regimen manageability compared with infusion-based options
• Clinical familiarity and established use patterns in oncology practices

In business terms, this translates to a remaining market mainly driven by:

• Existing prescriber behavior
• Formularies that still support lapatinib in later-line chemotherapy combination contexts
• Continued presence of lapatinib in treatment algorithms for specific patient profiles

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Investment and R&D implications

For R&D strategists and investors, TYKERB is more relevant as a reference point than as a growth engine:

• Its modern commercial performance is dominated by competitive displacement rather than incremental label expansion.
• The long-term ceiling is set by how quickly HER2 algorithms exclude older TKIs in favor of ADC-centric and next-generation regimen strategies.

The main actionable read-through is that future HER2 small-molecule strategies need:

• Clear differentiation by line-of-therapy positioning
• Evidence against ADC or newer TKI sequencing
• A path to market access that survives label churn

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Key Takeaways

• TYKERB (lapatinib) is a legacy HER2 EGFR TKI used in HER2-positive breast cancer, historically anchored in combination regimens in advanced disease.
• A current, registry-accurate clinical trials update cannot be generated from the available information set.
• The market has faced sustained HER2 treatment algorithm shift toward antibodies, ADCs, and newer TKIs, limiting growth potential.
• A numeric market projection cannot be produced without an auditable baseline sales/utilization series.

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FAQs

1) Is TYKERB still used in HER2-positive metastatic breast cancer?
Yes. TYKERB remains an option in HER2-positive advanced settings, primarily within combination regimens where it fits existing evidence and sequencing.

2) What targets does TYKERB inhibit?
TYKERB (lapatinib) inhibits EGFR (ERBB1) and HER2 (ERBB2).

3) What is the main competitive pressure on TYKERB?
Modern HER2 algorithms increasingly favor ADCs and newer HER2-directed therapies, which can displace older TKIs in later lines.

4) Does TYKERB have growth potential versus newer HER2 agents?
Growth is structurally constrained by legacy positioning and regimen displacement; TYKERB’s market presence tends toward niche maintenance rather than expansion.

5) Can you provide a current forecast with numbers?
Not from the provided information set, which lacks a validated current-year revenue baseline and utilization trend inputs needed for an accurate projection.

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References

[1] No sources were provided in the prompt for clinical trials status, current sales, or market data specific to TYKERB.