Tyverb - lapatinib

What is Tyverb?

Tyverb is a drug containing the active substance lapatinib, available as yellow oval tablets (250 mg).

What is Tyverb used for?

Tyverb is indicated in the treatment of patients with advanced or metastatic breast cancer, whose tumor "expresses" large amounts of ErbB2. This means that the cancer produces (ie expresses) on the surface of the tumor cells large amounts of a specific protein, ErbB2 (also called HER2). The term "metastatic" indicates that the tumor has spread to other parts of the body.

Tyverb is used in combination with capecitabine (another anticancer medicine). Tyverb is only used if the disease is progressing after patients have received treatment that must have included anthracycline and a taxane (other types of anticancer drugs) and therapy with trastuzumab (another medicine used to treat cancer) for illness. metastatic. The medicine can only be obtained with a prescription.

How is Tyverb used?

Treatment with Tyverb should only be started by a doctor experienced in administering anticancer drugs.

The recommended dose of Tyverb is five tablets once a day. All five tablets should be taken at the same time, at least one hour before or at least one hour after meals. Each patient should take the medicine at the same time each day in relation to meals, such as always before a meal or always after a meal. The doctor may decide to suspend or stop therapy in patients who report certain side effects, especially those affecting the heart, lungs or liver. If Tyverb is restarted, the dosage may need to be reduced. Patients who have stopped treatment due to severe liver disorders are advised not to take the drug again.

Tyverb should be used with caution in patients with severe renal impairment or moderate to severe liver failure.

How does Tyverb work?

Lapatinib, the active substance in Tyverb, belongs to a class of medicines called protein kinase inhibitors. These compounds act by inhibiting a class of enzymes known as protein kinases, which may be present in certain receptors on the surface of tumor cells, including the ErbB2 protein, an epidermal growth factor receptor. ErbB2 stimulates cells to divide uncontrollably. By blocking these receptors, Tyverb helps reduce cell division. About a quarter of breast cancers express ErbB2.

How has Tyverb been studied?

The effects of Tyverb were first tested in experimental models before being studied in humans.

The efficacy of Tyverb was examined in a main study involving 408 women with advanced or metastatic breast cancer that expressed large amounts of ErbB2. Although the patients had already been treated with anthracycline, taxanes and trastuzumab, the disease had progressed or had recurred. The study compared the effectiveness of Tyverb in combination with capecitabine with a therapy based exclusively on capecitabine. The main measure of effectiveness was the time to progression of the disease, determined on the basis of scans carried out every six weeks.

What benefit has Tyverb shown during the studies?

Tyverb in combination with capecitabine was more effective than capecitabine alone. On average, according to the patients' medical assessment, the addition of Tyverb extended the time to disease progression from 18.3 to 23.9 weeks. However, at the time of the evaluation of the medicine, it was difficult to determine in the context of this study whether the addition of Tyverb had prolonged the survival time of patients or not.

What is the risk associated with Tyverb?

The most common side effects reported with Tyverb in combination with capecitabine (seen in more than one in ten patients) are diarrhea (which can lead to dehydration), nausea, vomiting, rash, anorexia (loss of appetite), fatigue, dyspepsia (indigestion)), dry skin, stomatitis (inflammation of the mucous membrane of the oral cavity), constipation, abdominal pain, palmar-plantar erythrodysesthesia (redness and pain in the hands and feet), pain in the extremities, lumbago (back pain), inflammation of the mucous membranes (membranes that cover hollow organs) and insomnia (difficulty sleeping). For the full list of all side effects reported with Tyverb, see the Package Leaflet.

Tyverb should not be used in people who are potentially hypersensitive (allergic) to lapatinib or any of the other ingredients of the medicine.

Why has Tyverb been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Tyverb's benefits, in combination with capecitabine, outweigh its risks in the treatment of patients with advanced or metastatic breast cancer, whose cancer overexpresses the ErbB2 (HER2 ) and therefore recommended that the product be given marketing authorization.

Tyverb has obtained "conditional approval". This means that more information on the medicine will be available in the future, especially regarding its effects on patient survival and the spread of breast cancer. The European Medicines Agency (EMEA) reviews the new information available every year and, if necessary, updates this summary.

What information is still awaited for Tyverb?

The company that makes Tyverb will provide an updated analysis of the effects of Tyverb on the survival time of patients in the main study. It will also perform a study to compare the efficacy of Tyverb therapy and a trastuzumab-based therapy on brain tumor spread.