GlaxoSmithKline announced 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 over-express ErbB2 (HER2). Patients should have progressive disease following prior therapy which must include anthracyclines, taxanes and therapy with trastuzumab in the metastatic setting.
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. 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 Europewith ErbB2 positive breast cancer and are at a greater risk of disease progression and death compared to women with tumours that do not over-express this protein," said Dr Martine Piccart, Professor of Oncology, Université 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".
"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 (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".