Yesterday, the Federal Drug Administration (FDA) granted Roche subsidiary Genentech’s pertuzumab regular approval for treatment for HER2-Positive early breast cancer patients at high risk of recurrence. Under the market name of Perjeta, this drug was approved for use in combination with trastuzumab and chemotherapy as adjuvant treatment clinical treatment following a successful trial involving 4804 patients with HER2-positive early breast cancer who had their primary tumor excised before the study.
In the randomized study, patients received either petuzumab or a placebo. The trial outcome measured invasive disease-free survival (IDFS). Adverse effects of a pertuzumab treatment used in combination with trastuzumab and chemotherapy were experienced by 30% of study patients, with diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting being the most common symptoms reported by trial participants.
In 2012, the Food and Drug Administration gave approval to pertuzumab for its use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer that had not received prior anti-HER2 therapy or chemotherapy.
The FDA had also previously granted accelerated approval for this drug as neoadjuvant treatment in 2013. This approval expands it use as a treatment option for those diagnosed with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk for recurrence.
Roche’s Chief Medical Officer and Head of Global Product Development Sandra Horning, MD said in a statement, “The goal of treating breast cancer early is to provide people with the best chance for a cure. While we come closer to this goal with each advance, many people still have a recurrence and progress to the metastatic stage…Today’s approval of Perjeta means people with HER2-positive early breast cancer at high risk of recurrence have a new, clinically meaningful treatment option to reduce the chances of their disease returning.”
For more on this new treatment option, visit the FDA website here. Please take a look at the resources we’ve listed on our website if you’ve been diagnosed with cancer and need help paying for cancer treatment, prescriptions or other health care costs.