Article & Journal Resources

By MarketWatch

Edited Press Release

LONDON (MarketWatch) -- GlaxoSmithKline announced Friday that Tyverb (lapatinib) has received a positive opinion recommending a conditional marketing authorisation from the European Medicines Agency (EMEA).
Lapatinib, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2).

Patients should have progressive disease following prior therapy which must include anthracyclines, taxanes and therapy with trastuzumab in the metastatic setting. 1.
Lapatinib is the first oral, small molecule dual targeted therapy that works by getting inside the cancer cell to inhibit both ErbB1 (EGFR) and ErbB2 (HER2), two receptor proteins which are responsible for tumour growth. 2 This novel mechanism of action is a new way to treat breast cancer.

"This positive opinion is fantastic news for eligible women with ErbB2-positive breast cancer across the European Union. Thousands of women are diagnosed every year in Europe with ErbB2 positive breast cancer and are at a greater risk of disease progression and death compared to women with tumours that do not overexpress this protein," said Dr Martine Piccart, Professor of Oncology, Universite Libre de Bruxelles and Department Head, Medicine, Jules Bordet Institute, Brussels. "Lapatinib represents an important new treatment option for a group of patients in real need of alternative therapies and I look forward to the day that I can prescribe lapatinib.

Not only that, but this is just the beginning given the ongoing clinical programme investigating the potential use of lapatinib in earlier stages of the disease."
The positive opinion was based on a pivotal Phase III trial (EGF100151) in which women with advanced or metastatic ErbB2-positive breast cancer whose disease had progressed following prior treatment were given either the combination of lapatinib and capecitabine, or capecitabine alone. The data showed that the analysis of investigator reported median time to progression (TTP) was 23.9 weeks in the lapatinib and capecitabine arm versus 18.3 weeks in the capecitabine arm alone.

In addition to the achievement of the primary endpoint, results from the trial demonstrated the associated potential to reduce the incidence of brain metastases as the first site of recurrence in metastatic breast cancer. Progression of brain metastases was 2% in the combination arm compared with 6% in the capecitabine alone arm. 7 Central nervous system metastases are a major burden for breast cancer patients. 8 These preliminary results with lapatinib are encouraging and are the basis of ongoing research in this area. Latest data on the use of lapatinib and capecitabine in brain metastases will be presented at the San Antonio Breast Cancer Symposium (SABCS) on Dec. 16, 2007.

The most common adverse events during therapy with lapatinib plus capecitabine were gastrointestinal (diarrhoea, nausea and vomiting) or skin disorders (rash and hand and foot syndrome). The majority of adverse events were mild to moderate in severity and were not significantly higher than those seen with capecitabine monotherapy. 5
A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required.
In the case of lapatinib, GSK is to provide further data from the pivotal study and also additional demonstration of decreased incidence of relapse in the central nervous system, for which a study will be conducted. A conditional marketing authorisation is valid for one year. Thereafter, the conditional marketing authorisation may be renewed annually.

"This is an extremely significant development for patients and physicians across Europe as lapatinib, in combination with capecitabine, will play a valuable role in treating an especially aggressive form of advanced breast cancer by providing an effective treatment that offers added convenience as an oral therapy," said Paolo Paoletti, SVP and Global Head of the Oncology Medicine Development Centre at GSK.
Andrew Witty, President, Pharmaceuticals Europe, GSK and CEO designate added, "The innovative mechanism of action of lapatinib represents a new way to treat breast cancer patients. It is also important to note that this is GSK's second EMEA positive opinion for a cancer treatment in a matter of months, following the positive opinion and approval of Atriance(R) (nelarabine) in the summer. These positive opinions underscore our commitment to develop an industry leading oncology portfolio to address the unmet medical needs of cancer patients, whether they be for highly prevalent or extremely rare forms of the disease."

A comprehensive clinical development programme will evaluate lapatinib both alone and in combination with other therapies (chemotherapy, hormonal therapy, other targeted agents and VEGF inhibitors) across the spectrum of ErbB2-positive breast cancer, from metastatic to early breast cancer. Trials are also ongoing and planned in a range of other solid tumours that overexpress ErbB1 and/or ErbB2.

GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK's revolutionary ' bench to bedside' approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes partnerships with more than 160 cancer centres. GSK is closing in on cancer from all sides with a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.
-Contact: 201-938-5400 End of Story