Every October, pink ribbons appear across the country for Breast Cancer Awareness Month. For me, this awareness is deeply personal; my grandmother lost her life to breast cancer 16 years ago. But this year, those ribbons come with real reason for hope.
Breast cancer has been documented for thousands of years. For most of that history, a diagnosis meant highly invasive surgery, harsh one-size-fits-all treatments, or often no effective options at all. Today, we are in the midst of a scientific renaissance in how we detect and treat this disease.
Doctors can now test a tumor’s receptors and genes to classify each cancer and match patients with targeted, personalized therapies. New classes of drugs, smarter ways to decide who gets which treatment, and blood tests that catch molecular warning signs before a tumor visibly grows are changing what a diagnosis means. Some new drugs can deliver cancer-destroying medicine directly to tumor cells.
At the Food and Drug Administration, we work relentlessly to get these breakthroughs to patients quickly by approving safe and effective drug products without cutting corners. Under the Trump administration, we are expediting reviews and making it easier to run efficient clinical trials here on American soil.
The results are real. In the past year alone, the FDA has approved 10 new breast cancer treatments for different stages of the disease. These include datopotamab deruxtecan for patients with advanced triple-negative breast cancer, and new uses of trastuzumab deruxtecan for certain patients with early-stage HER2-positive breast cancer.
We are also helping doctors get ahead of the disease instead of reacting to it. We recently approved camizestrant, a new hormone therapy, together with a companion blood test called Guardant360 CDx. The test periodically checks for ESR1 mutations in tumor DNA circulating in the blood. This lets doctors switch a patient’s treatment before the cancer shows up as a progression on scan, a first of its kind approach.
Artificial intelligence is also making a difference. FDA reviewers use AI to eliminate duplicative tasks and speed up the review of new products. We have also authorized AI-powered devices that help radiologists read mammograms and catch cancer earlier, as well as ArteraAI Breast, which helps predict a patient’s risk of metastasis to personalize their cancer treatment.
Few people know that the FDA oversees inspections of mammography facilities in America under the Mammography Quality Standards Act. That requires that your mammogram be performed by a qualified technologist, on equipment that has been tested, and is read by a qualified physician. It also means that you and your doctor get results clearly and promptly.
Patients themselves have never been more important to this work. Patient advocacy groups have directly shaped research priorities and clinical trial designs, and we will keep relying on their expertise as we move forward.
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So, this October, when you see the pink ribbon in your day-to-day lives, take a moment to learn more. If you are 40 years or older, talk to your doctor about screening. If breast cancer runs in your family, ask whether you should start earlier or consider counseling or possibly genetic testing. Early detection remains one of the most powerful tools we have.
Every approval, every new tool, and every screening brings us closer to a day when breast cancer is no longer a death sentence for anyone. We will continue fighting for faster cures and better outcomes, not just during Breast Cancer Awareness Month, but every day.
Kyle Diamantas is acting commissioner at the U.S. Food and Drug Administration.
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[ H/T Washington Examiner ]
