Switzerland’s Roche has received a new approval from European regulators for Herceptin, this time in combination with hormonal therapy for the treatment of advanced breast cancer.
The European Commission has given the go-ahead for the use of Herceptin (trastuzumab) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. The approval is based on data from the Phase III TAnDEM study which evaluated Herceptin in combination with AstraZeneca's Arimidex (anastrozole), an aromatase inhibitor, to Arimidex alone in 208 patients.
Median progression-free survival, the primary endpoint of the trial, was 4.8 months for patients who received the combination compared to 2.4 months for patients who received anastrazole alone. Patients in the combination arm also responded significantly better to treatment (20.3% versus 6.8%) and there was also a positive trend in median overall survival (28.5 months versus 23.9 months.
William Burns, head of Roche Pharma, said that the approval means that “for the first time a combination of targeted therapies is available for patients who suffer from a particularly aggressive form of breast cancer". He added that "Herceptin consistently benefits patients regardless of whether it is given in the early- or advanced-stage settings, or whether it is in combination with chemotherapy, hormonal therapy, or as a single agent."
Herceptin, which is likely to benefit financially from this new approval, is already a huge earner for the Basel-based drugmaker and had first-quarter sales of 1.17 billion Swiss francs, or around $962 million and an increase of 36% on the previous quarter.