FDA grants RMAT designation to CAR T-cell therapy for Hodgkin lymphoma subset
The FDA granted regenerative medicine advanced therapy designation to Tessa Therapeutics’ CD30-directed autologous chimeric antigen receptor T-cell therapy for the treatment of patients with relapsed or refractory CD30-postive classical Hodgkin lymphoma, according to a press release issued by the manufacturer.
The therapy is a genetically modified autologous CAR T-cell therapy that targets the CD30 protein on the surface of cancer cells.
The FDA’s regenerative medicine advanced therapy (RMAT) designation is based on clinical trial data from two ongoing independent phase 1/phase 2 studies of the therapy at Baylor College of Medicine and The University of North Carolina Lineberger Comprehensive Cancer Center. Eighteen of 27 patients (66.6%) treated so far have achieved complete responses to therapy, with an objective response rate of greater than 70%, according to the agent’s manufacturer.
“The RMAT designation speaks to the strength of the data ... which show promising efficacy and a strong safety profile of the therapy in [patients with Hodgkin lymphoma] whose disease had failed to respond to other available therapies,” Ivan D. Horak, MD, president of research and development at Tessa Therapeutics, said in the press release. “We look forward to working closely with the FDA as we advance our trial at multiple sites in North America and work to bring this potentially transformative treatment option to patients.”
The FDA’s RMAT designation program is part of the 21st Century Cures Act. The program was created to expedite review of regenerative medicine therapies intended to treat, modify, reverse or cure serious or life-threatening diseases or conditions.
The therapy must have preliminary clinical evidence indicating the drug has the potential to address unmet medical needs for such a disease or condition.