Cell Medica, a leader in developing cellular immunotherapy for the treatment of cancer, has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead oncology product CMD-003 for patients with relapsed/refractory lymphoma and post-transplant lymphoproliferative disease associated with the oncogenic Epstein Barr Virus (EBV).
CMD-003, also known as baltaleucel-T, is an investigational therapy in which the patient’s T cells are activated to kill malignant cells expressing EBV antigens. The product has the potential to address a range of EBV-associated lymphomas, nasopharyngeal carcinoma and gastric cancer. The FDA Fast Track designation follows Orphan Drug Designations from both the FDA (EBV-associated non-Hodgkin lymphoma) and European Commission (extranodal NK/T lymphoma, nasal type and post-transplant lymphoproliferative disease).
The FDA’s Fast Track is a process designed to facilitate the development and to expedite the review of drugs to treat serious conditions and fill an unmet medical need. The FDA will take appropriate actions to advance the development and review of the application for approval of such a product. FDA Fast Track status also allows for more frequent interactions with the FDA review team and a rolling Biologics License Application (BLA) for earlier product review.
CMD-003 is currently being investigated in the international, open label Phase 2 CITADEL clinical trial for patients with extranodal natural killer T cell lymphoma (ENKTCL), a type of non-Hodgkin lymphoma. Cell Medica has also opened the Phase 2 CIVIC clinical trial to explore the potential benefits of CMD-003 for patients with EBV-associated diffuse large B cell lymphoma (DLBCL), Hodgkin lymphoma, and post-transplant lymphoproliferative disease (PTLD).
Dr Kurt Gunter, Chief Medical Officer of Cell Medica, said “The Fast Track designation supports the potential for CMD-003 to address an important area of high unmet clinical need. The potential eligibility for accelerated approval and priority BLA review will help facilitate the development of our lead cancer immunotherapy candidate. We are committed to bringing this novel treatment to patients as soon as possible.”