# Lunsumio VELO (mosunetuzumab) + Polivy (polatuzumab vedotin) PDUFA Event: Relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma

Canonical URL: https://biopharmsignal.com/pdufa-calendar/RHHBY/lunsumio-velo-polivy-relapsed-refractory-large-b-cell-lymphoma

Ticker: RHHBY

Company: Roche Holdings AG

Event date: 2027-02-09

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: sBLA

FDA decision expected. FDA is expected to decide on Roche’s sBLA for subcutaneous Lunsumio VELO in combination with Polivy by February 9, 2027.

## Event Timeline

### February 9, 2027 — FDA decision expected

FDA is expected to decide on Roche’s sBLA for subcutaneous Lunsumio VELO in combination with Polivy by February 9, 2027.

[Roche — sBLA acceptance and FDA decision date](https://www.roche.com/investors/updates/inv-update-2026-06-18)

### June 18, 2026 — FDA accepted the sBLA for review

FDA accepted the supplemental BLA for the outpatient-ready Lunsumio VELO plus Polivy regimen in relapsed or refractory large B-cell lymphoma.

[Roche — sBLA acceptance](https://www.roche.com/investors/updates/inv-update-2026-06-18)

### June 18, 2026 — SUNMO Phase 3 results supported the filing

At 23.2 months’ median follow-up, Lunsumio VELO plus Polivy reduced the risk of progression or death by 59% versus R-GemOx and produced median progression-free survival of 11.5 months versus 3.8 months.

[Roche — SUNMO Phase 3 data](https://www.roche.com/investors/updates/inv-update-2026-06-18)

## Related Pages

- RHHBY PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/RHHBY.md

- RHHBY company profile: https://biopharmsignal.com/company/RHHBY.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

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