Onco-Summaries: Daily Oncology Updates at a Glance

18/06/2026

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• US FDA accepts Roche’s sBLA for subcutaneous Lunsumio + Polivy in relapsed/refractory LBCL

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US FDA accepts Roche’s sBLA for subcutaneous Lunsumio + Polivy in relapsed/refractory LBCL (Ref)

The US FDA has accepted Roche’s supplemental Biologics License Application (sBLA) for subcutaneous Lunsumio VELO (mosunetuzumab; CD20xCD3 T-cell engaging bispecific antibody) + Polivy (polatuzumab vedotin; CD79b targeting antibody-drug conjugate) in adults with relapsed/refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after ≥1 prior systemic therapy

FDA approval decision expected by February 9, 2027

Filing was based on Phase III SUNMO trial results:

• 59% reduction in risk of progression or death vs. R-GemOx (HR 0.41, p<0.0001)

• Median progression-free survival (PFS): 11.5 mos vs 3.8 mos for R-GemOx

• Safety profile consistent with known individual drug profiles; CRS incidence low (≤5% Grade 2/3)

• Longer follow-up confirmed sustained benefit, especially in second-line setting, with no new safety signals