Shots:

• The sBLA is based on the P-III (TRANSFORM) trial to evaluate Breyanzi (CD19-directed CAR T cell) vs SoC in adults with r/r LBCL, followed by high-dose CT plus autologous HSCT. The US FDA has accepted the application for priority review with an anticipated PDUFA date of June 24, 2022
• The results showed an improvements in event-free survival, CR & PFS, positive trend in OS in patients with LBCL whose disease was primary r/r within 12mos. The results were presented at ASH 2021
• The therapy is also approved in the US & Japan for r/r LBCL after two or more lines of systemic therapy while Breyanzi’s MAA are currently under review for same indication in the EU, Switzerland and Canada

 Ref: Businesswire | Image: BMS