Darza­lex from J&J, Gen­mab scores FDA ap­proval in front­line mul­ti­ple myelo­ma use as Sanofi ri­val looms

As Sanofi awaits the FDA re­view of its mul­ti­ple myelo­ma drug — J&J and Gen­mab’s es­tab­lished ri­val treat­ment Darza­lex scored US ap­proval for use in treat­ment-naïve pa­tients.

Darza­lex — known chem­i­cal­ly as dara­tu­mum­ab — is a mon­o­clon­al an­ti­body that locks on to the CD38 mol­e­cule, which is high­ly ex­pressed on the sur­face of mul­ti­ple myelo­ma cells. On Thurs­day, the drug was ap­proved on top of the stan­dard-of-care com­bi­na­tion of the chemother­a­py borte­zomib, thalido­mide and the steroid dex­am­etha­sone (VTd) for new­ly di­ag­nosed pa­tients with mul­ti­ple myelo­ma who are el­i­gi­ble for au­tol­o­gous stem cell trans­plant.

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