BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)
Shots:
- The US FDA has accepted sBLA & granted priority review to BMS‘ Opdivo (nivolumab) + doxorubicin, vinblastine & dacarbazine (AVD) for the treatment of pts (≥12yrs.) with previously untreated Stage III or IV cHL (PDUFA: Apr 8, 2026)
- sBLA was supported by the P-III (SWOG S1826/ CA2098UT) trial assessing Opdivo + AVD in above mentioned pts to evaluate PFS as 1EP, along with key 2EPs, incl. OS & other measures of efficacy & safety
- Opdivo is a PD-1 immune checkpoint inhibitor that restores anti-tumor immune response by harnessing the body’s immune system for the treatment of multiple cancers
Ref: BMS | Image: BMS |Press Release
Related News: BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)
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