FDA Approves First Metastasis-Free Endpoint Treatment for Prostate Cancer
Breakthroughs and new treatments are moving faster than ever. Getting treatments approved by the U.S. Food and Drug Administration (FDA) is crucial whenever new options are making way to patients with cancer. In February 2018, the FDA approved apalutamide (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596768.htm) for the treatment of nonmetastatic prostate cancer that continues to grow despite treatment with hormone therapy, the first FDA-approved treatment for nonmetastatic, castration-resistant prostate cancer.
According to the National Cancer Institute, prostate cancer is the second most common form of cancer in men in the United States, with approximately 161,360 men diagnosed 2017 and 26,730 expected to die from the disease.
Per Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, “The FDA evaluates a variety of methods that measure a drug’s effect, called endpoints, in the approval of oncology drugs. This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment.”
Along the road to new treatment approvals, the FDA conducts a rigorous reviews of treatment applications. Once the necessary criteria are met, the treatment is approved, and patients have access to options not previously available.
Patient-centered care is a hallmark priority for ONS. As new treatments are approved, patients with cancer have new opportunities for their cancer journey. Keeping oncology nurses up to date (https://voice.ons.org/topic/us-food-and-drug-administration-fda) with the changing landscape of cancer treatments is crucial to providing the best possible care for patients.