Roche’s Lunsumio (mosunetuzumab) Receives EC’s Approval for the Treatment of Relapsed or Refractory Follicular Lymphoma
- The EC has granted conditional marketing authorization for Lunsumio to treat adult patients with r/r FL who have received 2 prior systemic therapies
- The approval was based on the P-I/II (GO29781) study evaluating the safety, efficacy & PK of Lunsumio which showed high CR rates & maintained responses for 18mos. with favorable tolerability, m-DoR (22.8mos.) after a median follow-up of 18.3mos., CR rate (60%), ORR (80%), and CRS (39%) which were generally low grade & cleared after treatment
- The 2 P-III (CELESTIMO & SUNMO) studies are now being conducted for Lunsumio as part of a comprehensive development programme i.e., Lunsumio + lenalidomide as 2L+ FL & Lunsumio + Polivy (polatuzumab vedotin) in 2L+ DLBCL
Ref: Globenewswire | Image: Roche
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