FDA grants fast track, RMAT designations to CAR-T for advanced non-Hodgkin lymphoma
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The FDA granted fast track and regenerative medicine advanced therapy designations to CB-010, a chimeric antigen receptor T-cell therapy, for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma.
The fast track designation applies to patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The regenerative medicine advanced therapy (RMAT) designation applies to patients with relapsed or refractory large B-cell lymphoma.
CB-010 (Caribou Biosciences) is an allogeneic, CD19-directed CAR T-cell therapy.
The investigational agent is genetically engineered using CRISPR/Cas9 hybrid RNA/DNA technology to insert a CD19-specific CAR and knock out PD-1 to boost CAR T-cell persistence.
“RMAT and fast track designations for CB-010 are important recognitions of the significant unmet patient need for an off-the-shelf cell therapy in the treatment of aggressive [B-cell non-Hodgkin lymphoma],” Rachel Haurwitz, PhD, president and CEO of Caribou, said in a company-issued press release. “We are encouraged that CB-010 has demonstrated early potential as an off-the-shelf cell therapy that may meaningfully rival autologous cell therapies.”
The phase 1 ANTLER trial is evaluating the efficacy and safety of CB-010 for adults with B-cell non-Hodgkin lymphoma, including those with diffuse large B cell lymphoma, primary mediastinal large B-cell lymphoma and high-grade B-cell lymphoma.
Fast track designation is designed to facilitate the development and advance the review of drugs that treat serious conditions and fill an unmet medical need.
The FDA’s RMAT designation program, part of the 21st Century Cures Act, is designed to expedite review of regenerative medicine therapies intended to treat, modify, reverse or cure serious or life-threatening diseases or conditions. Preliminary clinical evidence must indicate the therapy has the potential to address unmet medical needs.
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