Genentech’s Glofitamab Receives BLA & Priority Review from the US FDA to Treat r/r Large B-Cell Lymphoma
Shots:
- The BLA submission was based on the P-I/II clinical trial evaluating glofitamab in 2L+ LBCL patients (n=155) refractory to their most recent therapy (85.1%) or failed CAR T-cell therapy (33.1%)
- The results from the study depicted a CR in 40.0% of the patients (73.1% showed continued response @12mos. & mDoR was 18.4mos.), OR in 51.6%, median follow-up time of 13.4mos. The earlier cut-off data depicted a CR of 11.5mos. & 12mos. post-treatment 61% of patients maintained a CR, 92.6% remained progression-free
- Glofitamab is a CD20xCD3 T-cell engaging bispecific Ab. and is being assessed in P-III combination study (STARGLO) in patients with DLBCL
Ref: Businesswire | Image: Genentech
Related News:- Genentech’s Lunsumio (mosunetuzumab-axgb) Receives the US FDA’s Approval for Relapsed or Refractory Follicular Lymphoma
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