Diagnostic tests and criteria are not certified in this packet.

The packet lists two FDA records for cyclophosphamide products with an active market status: a cyclophosphamide injection solution (NDA, CDER, 2023-06-27) and FRINDOVYX (cyclophosphamide, NDA, CDER, 2023-06-07). The packet does not specify the indications for these records. FDA orphan drug designations are recorded for a CD20-CD47 bispecific fusion protein and for sepantronium bromide, with indications naming Burkitt lymphoma, and a designation for 6,8-bis(benzylthio)octanoic acid is recorded as withdrawn. An orphan designation does not indicate approval, development status, or availability.

Prognosis is not certified in this packet.

ClinicalTrials.gov records in the packet include early-phase studies in relapsed or refractory B-cell lymphomas, such as a venetoclax-based combination, anti-CD19 chimeric antigen receptor T cells, and nivolumab with or without varlilumab, along with a retrospective observational study of the toxicity of intensive treatment in adult Burkitt lymphoma and a biospecimen collection study in hematologic cancer. Several records cover broader groups of hematologic malignancies rather than Burkitt lymphoma alone. The intervention types represented include drug therapy, biologic therapy, procedural interventions, and gene therapy approaches. Active clinical trials for this condition are listed on ClinicalTrials.gov.