The FDA approved an oral combination of decitabine and cedazuridine tablets (Inqovi) with venetoclax for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude intensive induction chemotherapy — the first and only fully oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating-agent regimens that require frequent clinic visits. The approval was based on Study ASTX727-07 (ClinicalTrials.gov NCT04657081; results presented at the American Society of Hematology 2025 Annual Meeting, Blood, DOI 10.1182/blood-2024-198541), a single-arm, open-label trial of 101 evaluable patients. The complete remission rate was 41.6%, and the complete remission or complete remission with partial hematologic recovery rate was 52.5% — real, disclosed response-rate data from a single-arm trial.

The FDA approved Optune Pax, a Tumor Treating Fields (TTFields) delivery device, for adults with locally advanced pancreatic cancer, used alongside standard gemcitabine and nab-paclitaxel chemotherapy — the first TTFields approval outside the brain, lung, and mesothelioma cancers this device family has previously been approved for. TTFields work by emitting targeted alternating electric fields through arrays worn on the skin, designed to disrupt the electrical processes tumor cells depend on for division and survival. The approval was based on the randomized, open-label, phase 3 PANOVA-3 trial (ClinicalTrials.gov NCT03377491; primary publication in the Journal of Clinical Oncology, DOI 10.1200/JCO-25-00746), which enrolled 571 adults with locally advanced pancreatic adenocarcinoma. Overall survival — the trial’s primary endpoint — was longer with TTFields added to chemotherapy: median 16.2 months versus 14.2 months with chemotherapy alone (hazard ratio 0.82, P=.039), a real, statistically significant benefit.