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The EC has approved Johnson & Johnson’s Tecvayli (teclistamab; BCMAxCD3 bispecific) monotherapy for adults with RRMM who have received ≥1 prior therapy, replacing its current monotherapy indication & adding monthly dosing from mos 7 (or as early as mos 3)
Approval was based on the P-III (MajesTEC-9) trial vs PVd or Kd in pts with 1-3 prior LoTs, which showed a 71% reduction in risk of progression or death (HR=0.29) & 40% in risk of death (HR=0.60), with ≥CR of 65.9% vs 16.8%
The approval follows the EC’s Aug 2026 nod for Tecvayli + daratumumab as early as 2L RRMM
Ref: GlobeNewswire | Image: Johnson & Johnson | Press Release
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The post Johnson & Johnson Receives the EC’s Approval for Tecvayli (Teclistamab) Monotherapy to Treat R/R Multiple Myeloma from First Relapse appeared first on PharmaShots.
Johnson & Johnson Receives the EC’s Approval for Tecvayli (Teclistamab) Monotherapy to Treat R/R Multiple Myeloma from First Relapse | PharmaVoice