FDA may ease approval for breast cancer therapeutics

A new guidance document released by the FDA on Monday provides the means to accelerate the process for approving neoadjuvant therapeutic drugs for early-stage, high-risk breast cancer.

FDA officials indicated that the main aim of the initiative is to reduce unnecessary mastectomies.

“This guidance primarily describes potential pathways to accelerated approval for promising drugs in early stages of development for breast cancer,” the document notes. “An alternate approach is also outlined for drugs with more extensive prior clinical data, existing breast cancer or other oncologic indications, those being studied in ongoing randomized adjuvant breast cancer trials, or those with unprecedented efficacy observed in early breast cancer trials. Applicants should consult the FDA as early as possible regarding their development strategy when seeking a neoadjuvant breast cancer indication.”

The guidance excludes endocrine therapy for breast cancer, nor any other tumor types beyond those of the breast.