New Pre-Surgical (Neoadjuvant) Breast Cancer Drug is on the Road to Approval
Roche, a Swiss global health-care company, has recently received a positive review from the Food and Drug Administration (FDA) concerning their new pre-surgical breast cancer treatment drug, Perjeta.
In actuality, a positive review is an understatement. FDA scientists are recommending accelerating the approval process for the drug, a measure usually reserved for pioneering drugs that treat potentially fatal diseases. Why the rush? Well, in the study released by Roche (more specifically Genentech, a division within Roche) 417 women were sampled—comparing Perjeta in varying combinations against older breast cancer treatments. When Perjeta was combined with Herceptin and standard chemotherapy, 39 percent of woman saw their cancer reach undetectable levels while only 21 percent experienced the same result from taking Herceptin and chemotherapy alone.
It should be noted that Perjeta is only effective in a subset (about 20 percent) of breast cancer patients, more specifically those who have tumors that overproduce a protein known as HER-2.
While the FDA cautions that Genentech’s findings are preliminary and certainly need to be confirmed in future drug trials—the results are certainly exciting. Perjeta could potentially be the fist cancer drug approved for use as a pre-surgical step, Keep in mind that surgery to remove tumors is often the first step in treating virtually all forms of cancer—this could be a big step.
Breast cancer isn’t slowing down. The disease is expected to kill 39,000 Americans this year, according to the National Cancer Institute—roughly 7,000 of those deaths per year are attributed to the HER-2 form of the disease.
The FDA is expected to make a decision to approve or deny Perjeta or early stage breast cancer by the end of October. We will update this post then with the verdict.