Kite Receives EMA’s CHMP Positive Opinion for Yescarta (axicabtagene ciloleucel) to Treat Second-line Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma
Shots:
- The EMA’s CHMP has issued a positive opinion for Yescarta in adult patients with DLBCL & HGB. The EC’s decision is expected in the coming months
- The opinion was based on the P-III (ZUMA-7) study that evaluated Yescarta vs SOC, which showed a 4-fold greater improvement in 1EPs of EFS (8.3mos. vs 2.0mos.) at a median follow-up of 2yrs.; 2.5-fold in patients who were alive without disease progression or need for additional cancer treatment (41% vs 16%) along with improvements in EFS
- The therapy had a manageable safety profile consistent with prior studies, grade ≥3 CRS & neurologic events (6% & 21%) with no grade 5 CRS or neurologic events. A separate, secondary analysis of PROs showed improvements in QoL @Day 100 & trend toward faster recovery to baseline QoL
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
