Roche Holding AG (ROG)’s Perjeta helped shrink early breast-cancer tumors, U.S. regulators said, a benefit that may lead to less-invasive surgical treatment.
Perjeta, already on the market for women with advanced breast cancer that has spread, showed promise in the early stage of the disease, Food and Drug Administration staff said in a report today ahead of a Sept. 12 meeting of agency advisers to discuss the medication. Agency staff said cardiac concerns should be studied in future clinical trials.
Expanded clearance would mark the first cancer medicine approved in the U.S. as an initial step, which is referred to as neoadjuvant therapy. Roche’s Genentech unit estimates about 15,000 women with HER2-positive early-stage breast cancer could receive neoadjuvant treatment with Perjeta each year.
“Statistically significant improvements” in eradication of tumor tissue were seen in patients receiving Perjeta compared to those on Roche’s Herceptin, the FDA staff said.
Roche studied Perjeta’s ability to eradicate tumors when used with the Basel, Switzerland-based company’s older breast-cancer drug Herceptin and chemotherapy. The FDA may decide by the end of October whether to approve wider use of Perjeta.
Agency staff said Roche should conduct additional research on the effect of antibiotics used to destroy cancer cells on patients’ heart safety and the response to the Perjeta regimen depending on when the drugs are given.
The majority of people with HER2-positive early-stage breast cancer who receive neoadjuvant treatment receive a combination of Roche’s Herceptin and chemotherapy, Susan Willson, a Genentech spokeswoman, said. Therapy prior to surgery to attempt to shrink a tumor can conserve the breast opposed to having a mastectomy, Sandra Horning, global head of clinical development in hematology and oncology at Genentech, said in an interview.
Roche is asking the FDA for expanded use of Perjeta under accelerated approval, which is based on the likelihood the drug works on the condition that he company does more research typically to prove the drug extends disease-free survival.
The FDA released a draft proposal in May 2012 guiding companies to use tumor eradication as a study goal to gain accelerated approval for neoadjuvant breast cancer treatment.
Perjeta, first approved for advanced breast cancer in June 2012, may generate sales of $1.9 billion in 2016, according to the average of five analysts’ estimates compiled by Bloomberg. Herceptin brought in revenue of $6.3 billion last year. Roche also is studying another treatment, Kadcyla, in the neoadjuvant setting. Kadcyla, approved in February, is used with Herceptin to treat HER2-positive breast cancer that has spread.
A gene mutation causes the body to create excess HER2 protein that promotes the growth of cancer cells, according to the Mayo Clinic. HER2-postivie breast cancer tends to be more aggressive than other forms of breast cancer.
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