Genentech Reports the US FDA Acceptance of BLA and Granted Priority Review of Mosunetuzumab for Relapsed or Refractory Follicular Lymphoma
Shots:
- The BLA was based on the P-I/II (GO29781) trial evaluating mosunetuzumab. The US FDA decision for approval of the novel cancer immunotherapy is expected on Dec 29, 2022
- The results showed high & durable CR rates, responders maintained responses for 18mos. & has manageable tolerability in patients with heavily pretreated FL. After a median follow-up of 18.3mos., the CR rate (60%), ORR (80%), m-DoR (22.8mos.) in those who responded, CRS (39%) with low grade (grade 1: 25.6%; grade 2: 14%; grade 3: 2.3%; grade 4: 0.5%),
- The 2 P-III (CELESTIMO & SUNMO) studies are being conducted for mosunetuzumab as part of a comprehensive development program i.e., mosunetuzumab + lenalidomide as 2L+ FL & mosunetuzumab + Polivy (polatuzumab vedotin) in 2L+ DLBC
Ref: Bussinesswire | Image: Organon
Click here to read the full press release
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.
