Chugai’s Polivy Receives MHLW’s Approval for Relapsed or Refractory Diffuse Large B-cell Lymphoma

Shots:

  • The approval is based on results from P- Ib/II GO29365 study assessing Polivy (IV, 30 & 140mg) + BR vs BR alone in 80 DLBCL patients and P-II JO40762/P-DRIVE study that evaluated Polivy + BR therapy in 35 patients with R/R DLBCL not eligible for ASCT
  • The P-II part of GO29365 study demonstrated CRR (40% vs 17.5%) at (PRA 6-8wks. after the last dose of Polivy). P-DRIVE study demonstrated 34% CRR at the PRA
  • Additionally, the ongoing P-III GO39942/POLARIX study assesses the efficacy and safety of Polivy + R-CHP vs R-CHOP for untreated DLBCL

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