What is the generic name?

MELPHALAN FLUFENAMIDE

What is the Trade Name for MELPHALAN FLUFENAMIDE?

Pepaxto

What are the Indications for MELPHALAN FLUFENAMIDE?

• 1 INDICATIONS AND USAGE PEPAXTO is indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. 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 confirmatory trial(s) [see Clinical Studies (14) ] . PEPAXTO is an alkylating drug indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. ( 1 ) 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 confirmatory trial(s). ( 1 ) Limitations of Use : PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials. ( 1 , 5.5 ) Limitations of Use PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials [see Warnings and Precautions (5.5) ].

References: https://open.fda.gov/