FDA Grants P-BCMA-101 CAR T-Cell Therapy Orphan Drug Designation for Myeloma

May 14, 2019 – The FDA has granted an orphan drug designation to the autologous CAR T-cell therapy P-BCMA-101 for the treatment of patients with relapsed/refractory multiple myeloma. The designation is based on results of a phase I trial (NCT03288493), which demonstrated tolerability and responses with P-BCMA-101 in this patient population. “FDA orphan designation is an important regulatory milestone in the continued development and commercialization of … (leggi tutto)