linvoseltamab

FDA Drug Profile

Drug Details

Generic Name
linvoseltamab
Brand Names
N/A
Application Number
Sponsor
Regeneron Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
SOLUTION
Routes
N/A
Active Ingredients
LINVOSELTAMAB

Indications and Usage

1 INDICATIONS AND USAGE LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). LYNOZYFIC is a bispecific B-cell maturation antigen (BCMA)‑directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1 )