January new medicines approval recommendations from EMA/CHMP
Following the January meeting of the European Medicines Agency’s Medicinal Products for Human Use (CHMP) several drug recommendations were announced.
Most notable was the CHMP giving a positive opinion for the new gene therapy Breyanzi (lisocabtagene maraleucel), from US pharma major Bristol Myers Squibb (NYSE: BMY), for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two previous lines of treatment.
Since Breyanzi addresses an unmet medical need, it benefitted from support within the PRIority MEdicines (PRIME) scheme, the EMA’s platform for early and enhanced dialogue with developers of promising new medicines.
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