Genmab and AbbVie Report the US FDA Approval of Epkinly to Treat R/R Follicular Lymphoma
Shots:
- The US FDA has approved Epkinly (epcoritamab-bysp) + rituximab & lenalidomide (R2) for the treatment of adults with r/r follicular lymphoma (FL) & converted accelerated approval of Epkinly monotx. to full approval for r/r FL following ≥2L of systemic therapy
- Approval was based on P-III (EPCORE FL-1) trial assessing Epkinly + R2 (n=243)vs R2 alone(n=245)in r/r FL adults, incl. those who received ≥1L of therapy
- Trial showed a 79% reduction in risk of progression or death (mPFS not reached vs 11.2mos.) The combination achieved an ORR of 89% & CR rate of 74%, compared with 74% & 43% for R2, respectively; data will be presented at ASH’25
Ref: Genmab | Image: Genmab and AbbVie |Press Release
Related News:- Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma
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