Genentech’s Lunsumio (mosunetuzumab-axgb) Receives the US FDA’s Approval for Relapsed or Refractory Follicular Lymphoma
Shots:
- The US FDA has approved Lunsumio (CD20xCD3 T-cell engaging bispecific Ab) for r/r FL after ≥2 lines of systemic therapy. The product can be administered as an IV inf. for a fixed duration & expected to be available in the US in the coming weeks
- The approval was based on the P-II (GO29781) dose-escalation & expansion study evaluating Lunsumio in 836 patients with heavily pretreated FL who were at high risk of disease progression or whose disease was refractory to prior therapies
- The results showed high & durable response rates, ORR (80%) with a majority of patients-maintained responses for 18mos, m-DoR was (22.8mos.), CR (60%). The effects of lunsumio on earlier line therapies for non-lymphoma Hodgkin's patients are being studied in P-III studies as an SC formulation
Ref: Businesswire | Image: Genentech
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