Roche Holding AG’s Perjeta won expanded U.S. approval as the first pre-surgical therapy in breast cancer, increasing the odds the disease may be stopped in those diagnosed with early stage HER2-positive tumors.
Perjeta, which is to be used in combination with Basel, Switzerland-based Roche’s older breast cancer medicine Herceptin and chemotherapy, was approved under an accelerated process based on early clinical trials that showed the therapy reduced the size of tumors, the Food and Drug Administration said today in a statement. Roche must complete a trial confirming benefit in more than 4,800 enrollees who have had prior breast cancer surgery and are at high risk of their cancer returning, the FDA said.
“We are seeing a significant shift in the treatment paradigm for early stage breast cancer,” Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.”
Use of Perjeta prior to therapy may enable women to choose less invasive surgery than a mastectomy, Roche said when a panel of FDA advisers voted September 12 the benefits of the drug outweigh the risks. Perjeta was first approved in June 2012 for advanced HER2-positive breast cancer that has spread.
The FDA released a draft proposal in May 2012 guiding companies to use tumor eradication as a study goal to gain accelerated marketing clearance for pre-surgical breast cancer treatments in an attempt to speed approval of such drugs.
“A new approval pathway has made Perjeta available to people with HER2-positive early breast cancer several years earlier than previously possible,” Hal Barron, Roche’s chief medical officer, said in a statement. “Together with the FDA, we’ve charted new territory.”
Perjeta may generate $2.7 billion in sales for Roche in 2017, according to the average of six analysts’ estimates compiled by Bloomberg. The most common side effects of the drug are hair loss, diarrhea, nausea and a decrease in infection-fighting white blood cells.