EMA's Advisory Committee Recommends Approval Of Bristol-Myers' Breyanzi In Lymphoma

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bristol-Myers Squibb Co BMY Breyanzi (lisocabtagene maraleucel; liso-cel) for lymphoma settings.

• The recommendation covers Breyanzi for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy.
• The CHMP adopted a positive opinion based on TRANSCEND NHL 001, and additional data from the TRANSCEND WORLD study. 
• The EC is expected to deliver its final decision within 67 days of receiving the CHMP opinion.
• Price Action: BMY shares are up 0.77% at $64.35 during the market session on the last check Friday.