GlaxoSmithKline (GSK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued two positive opinions in the European Union for two of its cancer medicines.
The CHMP has issued a positive opinion for the authorisation of a new therapeutic indication for Tyverb (lapatinib) in the European Union. Lapatinib, in combination with an aromatase inhibitor (AI), is indicated for the treatment of post-menopausal women with hormone receptor (HR)-positive, HER2 (ErbB2) over-expressing metastatic breast cancer and for whom chemotherapy is currently not intended. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor.
The CHMP has also recommended the conditional marketing authorisation for Votrient (pazopanib), for the first-line treatment of advanced RCC and for patients who have received prior cytokine therapy for advanced disease. Once approved, both medicines will provide new, oral, targeted treatment options for eligible patients in Europe.
“In the past three months, the CHMP has issued four positive opinions for innovative cancer and haematology treatments researched and developed by GSK. We are proud that the rapid pace of our development programme is delivering products that may make a difference for those patients who continue to try and overcome these two types of cancers, which are challenging diseases to treat.” said Eddie Gray, president, GSK Pharmaceuticals Europe.
Lapatinib, first-line combination treatment, delays disease progression.
Lapatinib is the first oral, small-molecule, dual-targeted therapy for metastatic breast cancer that over-express ErbB2.
Pazopanib, a once-daily, oral medication, is an angiogenesis inhibitor, which may help prevent the growth of new blood vessels as well as acting directly on the cause of renal cell cancer.
In adults, 85-90 per cent of kidney cancers are RCC. In the EU, there were an estimated 63,300 new cases of kidney cancer and 26,400 deaths due to kidney cancer in 2006.7 RCC is the most common type of kidney cancer.