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. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor.
GSK said that the positive opinion from the CHMP is based on the results of study EGF30008. The randomised Phase III trial evaluated Lapatinib, in combination with letrozole, in women with HR-positive metastatic breast cancer which may or may not also over-express the HER2/ErbB2 receptor.
The results showed that combination therapy provided an improvement in progression-free survival (PFS) compared with letrozole plus placebo, in patients with HR-positive, ErbB2 over-expressing tumours. Patients given lapatinib plus letrozole experienced a median 8.2 months of PFS, compared with 3 months for those in the letrozole plus placebo group.
Additionaly, 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.
Reportedly, the CHMP positive opinion for a conditional marketing authorisation 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 improved progression-free survival compared to placebo, regardless of whether or not they had received prior therapy with cytokines. In the overall treatment population patients receiving Pazopanib experienced 9.2 months of median PFS, compared with 4.2 months for those in the placebo group. Treatment-naive patients who received Pazopanib experienced 11.1 months of median PFS, versus 2.8 months with placebo.
Furthermore, patients who had previously received cytokine-based treatment achieved 7.4 months of median PFS with Pazopanib versus 4.2 months with placebo.
Eddie Gray, president of GSK Pharmaceuticals in Europe, said: “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.”