Tabelecleucel, tab-cel® is an off-the-shelf, allogeneic T-cell immunotherapy in Phase 3 studies for patients with EBV+ PTLD (Epstein-Barr virus associated post-transplant lymphoproliferative disease), as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). PTLD is a type of cancer or lymphoma that may occur after bone marrow or organ transplant.
In February 2015, the FDA granted tabelecleucel Breakthrough Therapy Designation for Epstein-Barr virus associated post-transplant lymphoproliferative disorder following allogeneic hematopoietic cell transplant (HCT), and in October 2016, tabelecleucel was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. In addition, tab-cel® has orphan status in the U.S. and EU.
Tab-cel® is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study), and Atara recently initiated a Phase 1/2 study in NPC. Tab-cel® is also available to eligible patients with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options through an expanded access program.