Tykerb (Lapatinib) - Summary

TYKERB SUMMARY

TYKERB ^® (lapatinib) tablets

Lapatinib is a small molecule and a member of the 4-anilinoquinazoline class of kinase inhibitors.

TYKERB is indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.

See all Tykerb indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tykerb (Lapatinib)

FDA Approves Abemaciclib (Verzenio) for Advanced HR+ Breast Cancer
Source: Medscape Hematology-Oncology Headlines [2017.09.28]
The new drug is similar to two other cyclin-dependent kinase (CDK) 4/6 inhibitors, but it also has some distinguishing qualities.
FDA Approvals

Breast Cancer Radiation 'Less Scary' Than Thought
Source: MedicineNet Cancer Specialty [2017.09.26]
Title: Breast Cancer Radiation 'Less Scary' Than Thought
Category: Health News
Created: 9/25/2017 12:00:00 AM
Last Editorial Review: 9/26/2017 12:00:00 AM

Exercise After Breast Cancer Surgery Clears 'Brain Fog'
Source: Medscape General Surgery Headlines [2017.09.25]
Increased daily aerobic activity triples processing speed on both objective and self-rated cognition tests in previously sedentary breast cancer survivors.
Medscape Medical News

Yoga May Bring Better Sleep to Breast Cancer Patients
Source: MedicineNet Chemotherapy Specialty [2017.09.22]
Title: Yoga May Bring Better Sleep to Breast Cancer Patients
Category: Health News
Created: 9/22/2017 12:00:00 AM
Last Editorial Review: 9/22/2017 12:00:00 AM

Breast Cancer Quiz: Symptoms & Signs
Source: MedicineNet Breast Lumps In Women Specialty [2017.09.19]
Title: Breast Cancer Quiz: Symptoms & Signs
Category: MedicineNet Quiz
Created: 10/11/2010 12:00:00 AM
Last Editorial Review: 9/19/2017 5:02:57 PM

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Published Studies Related to Tykerb (Lapatinib)

Double-blind, placebo-controlled, multicenter, randomized, phase IIb neoadjuvant study of letrozole-lapatinib in postmenopausal hormone receptor-positive, human epidermal growth factor receptor 2-negative, operable breast cancer. [2014]
factor receptor 2 (HER2) -negative operable breast cancer... CONCLUSION: The combination of letrozole-lapatinib in early breast cancer was

Endocrine therapy with or without inhibition of epidermal growth factor receptor and human epidermal growth factor receptor 2: a randomized, double-blind, placebo-controlled phase III trial of fulvestrant with or without lapatinib for postmenopausal women with hormone receptor-positive advanced breast cancer-CALGB 40302 (Alliance). [2014]
metastatic breast cancer treated with fulvestrant... CONCLUSION: Adding lapatinib to fulvestrant does not improve PFS or OS in

Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. [2013]
in patients with HER2-overexpressing metastatic breast cancer (MBC)... CONCLUSION: This trial demonstrated that lapatinib combined with paclitaxel

Target-specific, histology-independent, randomized discontinuation study of lapatinib in patients with HER2-amplified solid tumors. [2012]
focused on the drug target rather than on histology... CONCLUSIONS: Basing trial eligibility on the presence of a genetic target, versus

Effects of lapatinib monotherapy: results of a randomised phase II study in therapy-naive patients with locally advanced squamous cell carcinoma of the head and neck. [2011.08.23]
BACKGROUND: Lapatinib is a dual inhibitor of epidermal growth factor receptor (EGFR) and human EGFR-2 (HER-2) tyrosine kinases. This study investigated the pharmacodynamic and clinical effects of lapatinib in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN)... CONCLUSION: Short-term lapatinib monotherapy did not demonstrate apoptotic changes, but provided evidence of clinical activity in locally advanced SCCHN, and warrants further investigation in this disease.

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Clinical Trials Related to Tykerb (Lapatinib)

Regulatory TYKERB� Tablets PMS [Completed]

Lapatinib and Cetuximab in Patients With Solid Tumors [Completed]
This trial is for patients with colon cancer, head and neck cancer and lung cancer that has not responded to standard therapy. Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or EGFR. It is thought that this receptor is turned "on" in some cancers, enabling cancer cells to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this receptor from the outside of cancer cells. It is thought that cancer cells can turn this signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been found that combining drugs that target both EGFR and ErbB2 might work better in turning this signal back off. The purpose of this study is to determine the maximum dosages that patients can tolerate when these two medicines are given at the same time. In addition, in order to be on this trial, patients must agree to have a tumor biopsy before starting treatment on this study and 21 days after starting treatment. These biopsies are a required part of the study. Patients must also agree to have blood drawn for research testing to see whether genetic differences between patients explain different reactions to and side effects from, these medicines.

A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase [Completed]
This phase II study is a single-arm, two-stage, multicentre study to determine the clinical activity of lapatinib in combination with pemetrexed in patients with Non-Small Cell Lung Cancer (NSCLC) who have received one prior cytotoxic chemotherapy regimen. There will be a short safety run in portion of the study to determine the optimal treatment regimen (OTR) for the combination, since these two drugs have not previously been used together. Approximately 27 patients will be enrolled into the first stage of the study and if sufficient responses are seen an additional 27 patients will be enrolled into the second stage giving an overall evaluable patient number of 54. Patients will be treated with pemetrexed plus lapatinib at the determined OTR to disease progression, death or withdrawal from the study treatment for any reason. Safety and efficacy assessments will be performed on all patients at 6-week intervals, as well as at the end of treatment. Patients withdrawn from study treatment with stable disease will be assessed every 6 weeks until progression. Thereafter, patients will be followed for survival at approximately 12-week intervals until death or to a maximum of 5 years after last patient is enrolled, whichever comes first.

Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer [Active, not recruiting]
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.

Lapatinib With Sirolimus or Metformin [Active, not recruiting]
The goal of this clinical research study is to find the highest tolerable dose of 2 different combinations of drugs that can be given to patients with advanced cancer. The first combination of drugs is Tykerb (lapatinib) and Rapamune (sirolimus), and the second combination is lapatinib and Glucophage (metformin). The safety of these drug combinations will also be studied.

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Reports of Suspected Tykerb (Lapatinib) Side Effects

Diarrhoea (332),  Death (117),  Nausea (106),  Fatigue (87),  Palmar-Plantar Erythrodysaesthesia Syndrome (84),  Rash (66),  Vomiting (60),  Decreased Appetite (46),  Erythema (44),  Disease Progression (44), more >>