The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of lisocabtagene maraleucel for adults with diffuse large B-cell lymphoma (LBCL), high grade B-cell lymphoma, primary mediastinal LBCL, or follicular lymphoma grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
The CHMP adopted a positive opinion based on results from the phase III TRANSFORM study. The study evaluated the chimeric antigen receptor (CAR) T-cell therapy as a second-line treatment in adults with relapsed or refractory LBCL and compared it to the standard of care, which consisted of salvage chemotherapy followed by high-dose chemotherapy plus hematopoietic stem cell transplant.
The European Commission will give its final decision within approximately two months following receipt of the CHMP opinion. The decision will be applicable to all European Union member states and Iceland, Norway, and Liechtenstein.
Source: Bristol Myers Squibb, March 2023