FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Business Wire
– Lunsumio VELO reduces administration time from 2-4 hours to approximately one minute –– Availability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences –– Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse – SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on veri
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