Shots:

• The EMA’s CHMP has adopted a positive opinion recommending approval of Breyanzi (CD19-directed CAR T cell therapy) in patients with r/r DLBCL, PMBCL & FL3B after 2+ lines of systemic therapy. The EC’s decision is expected within 67 days
• The opinion is based on a (TRANSCEND NHL 001) & (TRANSCEND WORLD study) of Breyanzi in patients with r/r DLBCL & 2 others indications who received Breyanzi in the inpatient & outpatient setting
• The EC’s decision will apply to all EU member states, Iceland, Norway & Liechtenstein. Breyanzi was approved in the US for r/r large B-cell lymphoma including DLBCL, primary mediastinal large B-cell lymphoma, FL3B & is also approved in Japan for r/r LBCL & FL

Ref: Businesswire | Image: BMS