I was recently invited to serve as a panelist for an FDA Oncology Center of Excellence mini-symposium. The oncology branch of the FDA has a mission of patient-centered decision-making guided by innovation and collaboration. To achieve that goal, the FDA occasionally invites oncologists and advocates working outside the FDA together for “mini-symposiums” to discuss emerging trends in drug discovery in oncology. Although the symposia are closed, regulatory agencies from other countries are invited to participate.
Experts presenting at the mini-symposium I attended covered topics ranging from current and future molecular targets in breast cancer, germline genetic mutations such as BRCA1 and BRCA2, liquid biopsies, and molecular profiling in the community. Stephanie Walker, a member of the Metastatic Breast Cancer Alliance, Living Beyond Breast Cancer volunteer, Komen volunteer, joined the panel as a patient advocate. In addition to sharing her story, she asked pointed questions about how personalized or genomic research could be accessible to patients and how we could implement genomic advances in a way to promote health equity for all patients.
The discussions were powerful. I participated in a previous in-person FDA mini-symposium, and I was worried that something would be lost over Zoom. But that wasn’t the case. The dialogue was rich and rewarding.
One highlight was our discussion on molecular tumor boards. We are increasingly performing complex testing on a person’s tumor. This is often referred to as molecular testing, genomic testing, or next-generation sequencing (NGS). NGS can be done on blood or tumor samples and looks at the gene signature of the cancer itself to identify alterations in those genes. Some of the alterations are actionable, meaning we have specific medicines to target them, like PIK3CA. Some are prognostic, meaning we know they may not respond as well to certain medicines or have a worse outcome, like ESR1. And some are meaningless noise, for now. The problem is that some of them can be all of those things. Molecular tumor boards led by specialists in NGS can help doctors and patients interpret results to determine how to use what they have learned from these tests.
A second highlight was Stephanie Walker challenging the panelists to look at variations in biomarkers in ways that incorporate race and ethnicity. Drug tolerance, metabolism, tumor response, biomarker frequency, or expression may differ across different populations. We need to expand the way we study breast cancer to find answers for everyone.
I’m proud that the FDA engages in these dialogues. If our regulators are committed to learning and growing, to bringing together unique voices to collaborate and engage, it will continue to help us accelerate drug discovery and work together to end breast cancer. I can’t wait to do it again.
