FDA eyes faster approval of chemotherapy treatments

The Food and Drug Administration (FDA) is looking to speed up the approval process for chemotherapies and other cancer drugs to treat early-stage breast cancer, the agency announced Monday.

In a guidance document, the FDA said it is looking to expedite the approval process to encourage industry to develop breakthrough chemotherapies, formally known as neoadjuvant treatment.

{mosads}The guidelines are intended to help pharmaceutical companies design trials that will get approved more quickly so they can begin marketing the breast cancer therapies before they’ve completed testing, the FDA noted.

The goal is to reduce the number of people who receive mastectomies by using innovative therapies instead, the FDA said.

“There are several potential reasons to consider neoadjuvant treatment for early-stage breast cancer,” the agency wrote. “Giving chemotherapy preoperatively permits breast conservation in some patients who would otherwise require mastectomy and may improve cosmesis in existing candidates for breast conservation.” 


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