Cellectar Biosciences Announces European Medicines Agency (EMA) Confirms Eligibility to File for Conditional Marketing Authorization (CMA) for Iopofosine I 131 as a Treatment for Refractory (postBTKi) Waldenstrom Macroglobulinemia (WM)

Image for article Cellectar Biosciences Announces European Medicines Agency (EMA) Confirms Eligibility to File for Conditional Marketing Authorization (CMA) for Iopofosine I 131 as a Treatment for Refractory (postBTKi) Waldenstrom Macroglobulinemia (WM)
News Source : Stocktitan.net

News Summary

  • Iopofosine I 131 meets eligibility requirements for a Conditional Marketing Authorization (CMA) filing in post-BTKi refractory Waldenstrom macroglobulinemia (WM) A CMA submission is expected in early 2026, with potential European approval and commercial launch across the EMA's 30 countries in 2027.
  • Clinical data include a CLOVER WaM Phase 2 overall response rate of 83.6% and major response rates of 58.2%.
Overall response rate 83.6% in CLOVER WaM Phase 2Major response rate 58.2% (95% CI 0.420.67)PRIME designation from EMA for WMPotential EU approval and launch in 202 [+14481 chars]

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