Roche's Perjeta has been approved in the EU for use before surgery in early stage breast cancer.
The European Commission (EC) approval covers the use of the drug to treat patients with HER2-positive breast cancer at high risk of recurrence, when used in combination with Roche’s older treatment Herceptin (trastuzumab) and chemotherapy before surgery. It already holds this indication in the US.
Pre-surgery, or neoadjuvant, treatment before the cancer has spread may reduce the chance of the disease returning.
“Today’s approval is a significant milestone in the neoadjuvant treatment of HER2-positive early breast cancer, bringing Perjeta to patients years earlier than typical adjuvant treatment,” says Sandra Horning, Roche’s chief medical officer and head of global product development. “We are committed to making the Perjeta regimen available to appropriate patients in the EU as early as possible.”
Perjeta (pertuzumab) is already approved in Europe for use in HER2-positive breast cancer that cannot be operated on in combination with Herceptin and chemotherapy.
However the drug is currently only available on the Cancer Drugs Fund in the UK, having been rejected by NICE due to its lofty £2,395 per 420mg vial price tag.
Perjeta has been a strong seller for Roche, though, and it has been seen as a key driver in sales growth for the company. It also helped to offset generic competition from Herceptin, which began to lose its patents in 2014.