The U.S. Food and Drug Administration approved 13 new cancer therapies in the second quarter of 2025, including a landmark new treatment regimen for head and neck cancer that marks the first major shift in care for the disease in over 20 years. The approvals also brought several first-ever options for patients with rare cancers and expanded the use of established immunotherapies.
The most significant advancement is the approval of perioperative pembrolizumab (Keytruda) for patients with PD-L1-positive, locally advanced head and neck squamous cell carcinoma (HNSCC). This approval establishes a new standard of care, moving beyond the long-standing paradigm of surgery followed by radiation and chemotherapy. The decision was based on phase III results from the KEYNOTE-689 trial, which showed that adding pembrolizumab before and after surgery reduced the risk of disease recurrence by 34% compared to standard therapy alone. Researchers hailed the data as a transformative step for a challenging disease.
This quarter also delivered progress for rare cancers, which often see slower therapeutic development due to limited patient populations and research models. Four new treatments were approved for rare malignancies, including the first-ever FDA approvals for penpulimab-kcqx for nasopharyngeal carcinoma and new options for squamous cell carcinoma of the anus, certain nervous system tumors, and ovarian cancer. Furthermore, the FDA expanded the use of the established immunotherapy combination of nivolumab and ipilimumab to include first-line treatment for certain colorectal and liver cancers, where it was previously reserved for later-line use.
The latest approvals also emphasized more precise treatment strategies. Two new antibody-drug conjugates for non-small cell lung cancer were approved, representing therapies designed to deliver potent chemotherapy directly to tumor cells while sparing healthy tissue. Another approval highlighted a localized approach for bladder cancer, where therapy is delivered directly into the bladder to minimize systemic side effects.
With these 13 new approvals, oncologists now have a broader arsenal to tailor treatment for both common and rare cancers. The quarter's decisions signal a continued shift toward immunotherapy-based regimens, targeted drug delivery, and a dedicated focus on filling unmet needs across the cancer landscape, offering renewed hope to patients.