US FDA grants Orphan Drug Designation to BCMA CAR-T cell therapy co-developed by Innovent Biologics and IASO Bio

ODD will accelerate drug development and registration action in the US

Innovent Biologics, together with IASO Biotherapeutics, recently jointly announced that the US Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) has formally granted Orphan Drug Designation (ODD) to their co-developed fully-human B-Cell Maturation Antigen (BCMA)-targetted Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM), Innovent Biologics said in a statement.

It also said that ODD will accelerate drug development and registration action in the US. IBI326 will be eligible for certain development incentives, including FDA support for clinical studies, a waiver or reduction of registration application fee, and a seven-year US market exclusivity granted upon product approval. In February 2021, IBI326 was granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA) for the treatment of R/R MM.

“FDA approval of ODD to CT103A is of great significance to patients with multiple myeloma and represents the FDA’s recognition of CT103A and the clinical data provided by IASO Bio,” said Dr Wen Wang, Chief Executive Officer and Chief Medical Officer, IASO Bio, in the statement.

He added, “Currently, our team is advancing the clinical development of CT103A to the four dimensions of strategy including frontline therapy, combination therapies, indication expansion and ex-China development. We are looking forward to the launch of CT103A both in China and the US as soon as possible to offer living-saving treatment option to more patients.”

Innovent BiologicsNational Medical Products AdministrationODDOrphan Drug DesignationUS FDA approval
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  • soundos

    Good article an excellent way to articulate. Keep it up