Roche has won the backing of a regulatory panel in the USA for Perjeta to be the first breast cancer treatment to be used before surgery.
The US Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 13 to 0, with one abstention, in favour of recommending accelerated approval of a Perjeta (pertuzumab) regimen for neoadjuvant treatment (ie use before surgery) in people with high-risk, HER2-positive early-stage breast cancer. If given the green light, the drug will be the first neoadjuvant treatment approved in the USA for the disease and the first based on pathological complete response (pCR) data, meaning there is no tumour tissue detectable at the time of surgery.
Perjeta is already approved for HER2-positive metastatic breast cancer in combination with Roche’s Herceptin ((trastuzumab) and docetaxel. However, Roche is seeking accelerated approval which it notes is “designed to more quickly bring promising medicines to people with earlier stages of breast cancer, where treatment may have a greater impact”.
The ODAC recommendation is based on two Phase II studies of Perjeta in high-risk, HER2-positive early-stage breast cancer, while an ongoing Phase III trial will further evaluate Perjeta in the adjuvant setting (after surgery) and compares Perjeta, Herceptin and chemotherapy with Herceptin and chemotherapy in people with HER2-positive early stage breast cancer. The study has completed enrollment with 4,800 people, and the primary endpoint is invasive disease-free survival; data are expected in 2016.