PDUFA WELIREG + LENVIMA LITESPARK-011 previously treated advanced ccRCC
The FDA’s decision on Merck &’s WELIREG (belzutifan) + LENVIMA (lenvatinib) for Advanced clear cell RCC after PD-1/PD-L1 therapy (LITESPARK-011) was due on Oct 4, 2026. The outcome isn’t recorded here yet — the linked source has the latest.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Merck & Co., Inc. MRK
- Drug
- WELIREG (belzutifan) + LENVIMA (lenvatinib)
- For
- Advanced clear cell RCC after PD-1/PD-L1 therapy (LITESPARK-011)
- Stage
- sNDA (Priority Review)
- When
- Oct 4, 2026
- Source note
- Eisai/Merck March 2, 2026 release on FDA acceptance of the LITESPARK-011 sNDAs; Merck's Aug 4, 2026 Q2 earnings slides also list 'LITESPARK-011 PDUFA date October 4th' among milestones expected in the next six months.
- Checked
- Checked by a person when it was added
- Source: eisai.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- MRK headlines on this site
Merck & expects to report results from its Phase 3 study of sacituzumab tirumotecan (MK-2870) for Advanced/recurrent endometrial cancer (TroFuse-005) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Sac-TMT TroFuse-005 endometrial cancer detailed Ph3 data presentation · Clinical trial results (readout / topline data)
- Drug
- sacituzumab tirumotecan (MK-2870)
- For
- Advanced/recurrent endometrial cancer (TroFuse-005)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Merck Aug 4, 2026 Q2 earnings slides list this under milestones 'expected over next six months' (Aug 2026-Jan 2027); no congress named, so H2 2026 is an approximation of that window. Topline (OS and PFS met) was announced in Q2 2026.
- Checked
- Checked by a person when it was added
- Verify it
- Source: merck.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- MRK headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page