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# Better Breast Cancer Biomarker Testing Needed: Pazdur
- URL: https://www.fdaweb.com/better-breast-cancer-biomarker-testing-needed-pazdur/
- Published: 2019-02-19T12:00:00.000Z
- Updated: 2026-09-15T01:05:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143415

FDA Oncology Center of Excellence director **Richard Pazdur** says although there has been recent progress in risk stratification in hormone receptor-positive breast cancer, there is a need for more sophisticated prognostic-biomarker testing to identify high-risk patients in time to intervene and improve outcomes. Writing in the *New England Journal of Medicine* (registration or subscription required), Pazdur [says](https://www.nejm.org/doi/full/10.1056/NEJMp1900079?ref=fdaweb.com) the availability of resected residual disease tissue provides opportunities to explore biomarker correlates that may be predictive of response to new agents.

“With a greater understanding of which patients derive benefit from a new agent,” he and his colleagues say, “subsequent trials could evaluate the drug preoperatively in a more targeted population. Meanwhile, residual disease after neoadjuvant treatment should be considered an important biomarker for patient selection in clinical trials in early breast cancer. Its use will increase both efficiency and the likelihood of success in developing new agents for patients with the greatest unmet need.”

The article reviews several drug trials as they relate to an FDA 2012 proposal to use the pathological complete response (pathCR) rate as a new regulatory endpoint to expedite development of drugs for high-risk early breast cancer. It says the pathCR rate can be assessed at the time of breast surgery within months after beginning investigational drug use, and patients who have a pathCR, defined as eradication of invasive tumor from the breast and lymph nodes after preoperative drug therapy, have a markedly improved prognosis.