FDA Flashback: Hematologic Cancer Decisions and News From September 2026

Get a concise overview of the FDA decisions and global regulatory news from September 2026 across hematologic malignancies. These include the approval in China of a noncovalent BTK inhibitor across all lines of therapy for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), the resubmission of a biologics license application (BLA) for an EBV–specific T-cell immunotherapy in EBV-positive post-transplant lymphoproliferative disease (PTLD), the acceptance of a new drug application (NDA) for a selective KIT D816V inhibitor in advanced systemic mastocytosis, and a fast track designation for an anti–galectin-9 antibody combination in relapsed/refractory high-risk myelodysplastic syndromes (MDS).