The German drugmaker plans to submit its data package for FDA approval by the end of the year, with potential approval next year. The package will include a synthetic control arm comprising real-world data.
A spokesperson for the company noted that patients in the Phase II L-MIND trial of the CD19-targeting drug tafasitamab would be too old and frail to be candidates for CAR-T therapies.
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The Phase I study is planned to enroll 24 patients with relapsed/refractory diffuse large B-cell lymphoma and follicular lymphoma and will be run under Allogene's collaboration with Servier.
Still, despite costs largely in line with the therapy's benefits, the study's author and another expert said reimbursement models have not kept up and need improvement.
A manufacturing error during a clinical trial of Kymriah, now marketed by Novartis, is less likely today, but could be an issue as CAR-Ts move into earlier therapy lines.
CMS could run trials of CAR-Ts in lymphoma if unsure of their similarity on benefit to patients and ancillary service costs, Dr. Peter Bach writes.
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