Q2 2025: 7 FDA Decisions to Watch in the Realm of Oncology

Following a busy first quarter marked by multiple high-impact approvals, the momentum heading into Q2 2025 is strong. Some Q1 highlights? Acalabrutinib (Calquence) plus bendamustine and rituximab (Rituxan) redefined standard first-line treatment for older patients with mantle cell lymphoma. In breast cancer, datopotamab deruxtecan and trastuzumab deruxtecan offer meaningful alternatives to conventional chemotherapy, including for patients with HER2-low or ultra-low disease. Durvalumab’s (Imfinzi) perioperative approval in muscle-invasive bladder cancer and lutetium Lu 177 vipivotide tetraxetan's (Pluvicto) earlier use in metastatic castration-resistant prostate cancer both signal shifts toward earlier intervention in historically difficult-to-treat settings.