Genentech, a member of Roche, announced that the FDA has approved Lunsumio for the treatment of adult patients with relapsed or refractory, or R/R, follicular lymphoma, or FL, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment. Lunsumio will be available in the United States in the coming weeks.
Published first on TheFly
See Insiders’ Hot Stocks on TipRanks >>
Read More on RHHBY:
- FDA approves Roche’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma
- FDA approves Genentech’s Lunsumio in refractory follicular lymphoma
- FDA approves Roche’s Actemra for the treatment of COVID-19 in hospitalised adults
- FDA approves Genentech’s Actemra for treatment of COVID-19 hospitalized adults
- Biogen reaches agreement with Genentech related to glofitamab commercialization