Midyear Roundup: FDA’s Novel Oncology Drug Approvals in 2025
In the first half of 2025, the FDA approved 7 novel drugs for oncologic conditions, including for non-small cell lung cancer; ovarian cancer; and metastatic, hormone receptor-positive, human epidermal growth factor 2-negative breast cancer.
Each year, the FDA approves dozens of novel medicines that have never been approved or marketed in the United States. These drugs are critical to patient populations impacted, who, before these approvals, often lacked a standard-of-care treatment option for their disease. Particularly in oncology, novel drugs are being developed at a rapid pace, expanding treatment capabilities for millions of patients with a form of cancer. It is critical for patients and providers alike to be aware of these novel drugs and their curative potential.1