Shots:
- The US FDA has accepted sBLA for Genentech‘s Lunsumio VELO (mosunetuzumab-axgb; SC) + Polivy (polatuzumab vedotin-piiq) for treating adults with r/r LBCL, incl. diffuse large B-cell lymphoma (DLBCL), after ≥1L of systemic therapy (PDUFA: Feb 9, 2027)
- sBLA was backed by the P-III (SUNMO) study assessing Lunsumio VELO + Polivy (IV) vs R-GemOx in the above pts who are ineligible for ASCT
- At an mFU of 23.2mos., the Lunsumio VELO & Polivy combination reduced the risk of disease progression or death by 59% vs R-GemOx & delivered a threefold longer mPFS (11.5 vs 3.8mos.)
Ref: Businesswire | Image: Genentech | Press Release
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