FDA panel recommends approval for pre-surgery treatment of early-stage breast cancer

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Each year, about 220,000 individuals are diagnosed with early-stage breast cancer, according to Genentech. For those 15,000 patients eligible for preoperative treatment neoadjuvant therapy due to size of tumor or other factors which may increase the surgical risk of operating on a bulky tumor, here s some encouraging news: The advisory committee to the FDA voted to advise approval for the first time, of a cancer drug, Perjeta, that could be used to treat breast cancer patients before surgery. Previously, this drug had only been approved for late-stage breast cancer. Using it pre-surgery may shrink some tumors, making it easier to operate on them, and even avoid total mastectomy (complete breast removal) in some patients.

Breast cancer is more successfully treated using drugs at an early stage after surgery adjuvant therapy. These drugs may reduce the risk of the cancer returning, although whether or not this treatment works takes years to see. According to Dr. José Baselga, physician in chief at Memorial Sloan-Kettering Cancer Center, Our current path to approval in early breast cancer is far too slow. So the decision by the FDA to allow drugs to be approved for use as a pre-surgery treatment is a step towards speeding up this process. This is evidenced by the fact that the trial for Perjeta as a pre-surgery treatment involved only 400 patients and lasted only twelve weeks.

Dr. Mikkael A. Sekeres, an associate professor at the Cleveland Clinic who served as chairman of the advisory committee said, This is a historic moment. We are supporting the rapid movement of a highly active drug for metastatic cancer to the first-line setting, with the hope that women with earlier stages of breast cancer will live longer and better.