The CHMP issued a positive opinion for the authorisation of a new therapeutic indication for Tyverb (lapatinib) in combination with an aromatase inhibitor, for the treatment of post-menopausal women with hormone receptor-positive, HER2 (ErbB2) over-expressing metastatic breast cancer and for whom chemotherapy is currently not intended.
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.
GSK Pharmaceuticals Europe’s president Eddie Gray said that in the past three months, the CHMP has issued four positive opinions for GSK’s cancer and haematology treatments.
The positive opinion from the CHMP is based on the results of a randomised Phase III trial, which evaluated lapatinib showing that combination therapy provided a significant improvement in progression-free survival.
Positive opinion for a conditional marketing authorisation of Votrient is based on data from a pivotal double-blind, Phase III study of 435 patients with advanced kidney cancer who had either received no prior drug treatment or had failed a cytokine-based treatment.
The results showed that pazopanib significantly improved progression-free survival compared to the placebo, regardless of whether or not they had received prior therapy with cytokines.