Genentech’s Columvi (glofitamab-gxbm) Receives the US FDA’s Approval for Relapsed or Refractory Diffuse Large B-cell Lymphoma
Shots:
- The US FDA has approved Columvi, a CD20xCD3 T-cell engaging bispecific Ab to treat adult patients with r/r DLBCL. The therapy will be commercially available in the US in the coming weeks
- The approval was based on the P-I/II dose-escalation and expansion study (NP30179) evaluating Columvi in 860 patients showed that the patients treated with fixed-duration Columvi achieved durable remission, ORR (56%), CR (43%), patients continued to respond for 9mos. (68.5%), m-DoR (1.5yrs.). The study results were published in the NEJM
- Cytokine release syndrome (70%), 52% experienced grade 1, and 14% grade 2. The company plans to provide patient assistance programs through Genentech Access Solutions
Ref: Businesswire | Image: Genentech
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