FDA Grants Fast Track Status to AB-101/Rituximab Combination

The US Food and Drug Administration (FDA) has granted Fast Track designation to AB-101 in combination with the anti-CD20 monoclonal antibody rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL), including in patients with failure of prior chimeric antigen receptor (CAR)-T treatment.

AB-101 is an allogeneic, cryopreserved, antibody-dependent cellular cytotoxicity-enhancing natural killer-cell therapy candidate derived from umbilical cord blood for use in combination with monoclonal antibodies or innate-cell engagers in the outpatient setting.

AB-101 is currently undergoing a phase I/II multicenter clinical trial at sites across the United States to assess its safety and clinical activity alone and in combination with rituximab in patients with relapsed or refractory B-cell NHL who have progressed beyond two or more prior lines of therapy, including CAR-T. In the trial, AB-101 is administered weekly in the outpatient setting over one-month cycles with up to four cycles to assess therapeutic efficacy and durability.

The developer of AB-101, Artiva Biotherapeutics, is also collaborating with biotech company Affimed N.V. to develop a combination therapy comprised of AB-101 and the innate cell engager AFM13 for patients with relapsed or refractory CD30-positive lymphomas, according to the company.

Source: Artiva Biotherapeutics press release, February 2023