The US Food and Administration has approved Roche's Perjeta (pertuzumab) for the treatment of an aggressive form of breast cancer.
The approval is based on a Phase 3 clinical trial which showed that people with HER2-positive breast cancer who received the drug in combination with Herceptin (trastuzumab) and chemotherapy, lived for six months longer than those who were treated with Herceptin plus chemotherapy only, without their disease getting worse.
According to Roche, the combined therapy is the only regimen to have shown a significant improvement in progression-free survival in people with previously untreated HER2-positive mBC.
Perjeta is designed to target the HER2 receptor, a protein found in high quantities on the outside of cells in HER2-positive cancers.
The drug is believed to work in a way that is complementary to Herceptin, as the two medicines target different regions on the HER2 receptor.
Herceptin has become standard therapy for patients with this tumour type. It binds to defective HER2 proteins, inhibiting the cells from multiplying out of control, but patients eventually develop resistance to the drug.
Chief medical officer and head of global product development, Hal Barron, said: "Perjeta attacks HER2-positive tumours differently than Herceptin. Based on the way the two medicines work together, the combination plus chemotherapy can prolong the time before this aggressive cancer worsens compared to Herceptin and chemotherapy alone."
"We are very pleased to see our efforts in studying the science of HER2 translate into another personalised medicine," added Barron.