Bristol Myers Squibb’s CAR-T Breyanzi Receives Recommendation for Approval from EMA’s CHMP
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol Myers Squibb’s Breyanzi to treat relapsed or refractory large B-cell lymphoma (R/R LBCL) in adult patients.
Breyanzi is intended to treat adult patients with R/R LBCL, high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) who relapse within 12 months of completing or are refractory to fine line chemoimmunotherapy using CAR-T cell therapy.
Breyanzi is a CD19-directed CAR-T cell therapy with a 4-1BB co-stimulatory domain that enhances the CAR-T cells’ expansion and persistence.
“This positive CHMP opinion is an important milestone towards introducing a potential new standard of care for people in the European Union living with relapsed or refractory large B-cell lymphoma after first-line treatment. […] We look forward to continuing to work with the European Medicines Agency, with the goal of bringing our cell therapy, Breyanzi, and the potential for cure to more people,” comments Anne Kerber, Bristol Myers Squibb Cell Therapy Development Senior VP.
The regulator’s positive opinion was based on the data gathered from the pivotal Phase III TRANSFORM trial, a randomized, pivotal, multicentre, global trial.
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The trial was designed to assess Breyanzi as a second-line treatment for R/R LBCL adult patients against the standard of care, which consists of varying chemotherapy and hematopoietic stem cell transplant.
The final decision from the European Commission (EC) is expected within around two months of receipt of the CHMP opinion. It will apply to all EU member states: Liechtenstein, Norway and Iceland.
Breyanzi is approved in Japan for the second-line treatment of R/R LBCL and in Japan, Europe, Switzerland and Canada for R/R LBCL after two or more lines of systemic therapy.
Source: Bristol Myers Squibb Press Release
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