FDA finalizes recommendations for enrolling males in breast cancer trials

In Clinical Studies News by Barbara Jacoby

By: Michael Mezher

From: raps.org

The US Food and Drug Administration (FDA) on Tuesday finalized guidance making recommendations to sponsors encouraging them to enroll male patients in breast cancer clinical trials.

The final guidance comes one year after the agency issued the draft version for comment and includes only minor changes from the previous iteration. (RELATED: FDA calls for men to be enrolled in breast cancer trials, 26 August 2019).

As in the draft version, FDA explains that breast cancer is rare in males, who account for less than one percent of breast cancer cases, and is often diagnosed at an older age and later stage of disease compared to female patients. However, FDA no longer states in the guidance that “The prognosis for males with breast cancer is similar to that for females with comparable stages of disease.”

FDA also expands on its recommendation for sponsors to discuss their drug development plans early with the relevant product center at the agency, noting that such discussions could cover the number of male patients who should be enrolled in clinical trials and what data should be gathered for specific development programs.

Additionally, the final guidance now recommends that sponsors including males in clinical trials for breast cancer drugs conduct nonclinical toxicology studies in both male and female animals. FDA refers sponsors to the International Council for Harmonisation’s (ICH) S9 Nonclinical Evaluation for Anticancer Pharmaceuticals guideline and corresponding questions and answers guideline, as well as its own Oncology Pharmaceuticals: Reproductive Toxicity and Labeling Recommendations guidance for further recommendations on gathering nonclinical data for oncology drugs. (RELATED: FDA adopts ICH guideline on nonclinical evaluation for anticancer drugs, Regulatory Focus 15 June 2018; Evaluating reproductive toxicity in oncology drugs: FDA finalizes guidance, Regulatory Focus 9 May 2019).