HealthDay News — The FDA has approved a new indication for pertuzumab (Perjeta, Genentech) to treat early-stage breast cancer before surgery, making it the first neoadjuvant for breast cancer.
The new indications is for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer who are at high risk of having their cancer metastasize or of dying from the disease, the agency said in a press release. It is intended for use in combination with trastuzumab (Herceptin) and other chemotherapy before surgery.
Pertuzumab was first approved in 2012 for use in combination with trastuzumab and docetaxel to treat advanced or late-stage metastatic HER2-positive breast cancer in women who had not previously received anti-HER2 therapy or chemotherapy.
Pertuzumab’s safety and effectiveness were evaluated for the new use in a clinical study involving 417 people that showed nearly half of HER2-positive breast cancer patients had complete responses when treated preoperatively with pertuzumab and trastuzumab plus chemotherapy.
A confirmatory study involving more than 4,800 people is ongoing with results expected in 2016, the FDA said.