Zepzelca labeling supplement to remove 2L ES-SCLC indication submitted to FDA
Zepzelca labeling supplement to remove 2L ES-SCLC indication submitted to FDA, in Q3 2026 (Jul–Sep). A company milestone for Jazz (Zepzelca (lurbinectedin) for ES-SCLC second-line): a step in the program rather than a decision or a data readout.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Jazz Pharmaceuticals plc JAZZ
- Drug
- Zepzelca (lurbinectedin)
- For
- ES-SCLC second-line
- Stage
- labeling supplement
- When
- Q3 2026 · the company gave a window, not a day; the calendar never invents one
- Source note
- Q2 2026 results PR (Aug 3, 2026). Post-LAGOON label cleanup; 1L maintenance (IMforte) indication unaffected.
- Checked
- Checked by a person when it was added
- Source: prnewswire.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
- JAZZ headlines on this site
Jazz expects to report results from its Phase 3 study of Modeyso (dordaviprone) for Recurrent H3 K27M-mutant diffuse glioma in the first half of 2027 (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
- Modeyso ACTION Phase 3 interim OS analysis · Clinical trial results (readout / topline data)
- Drug
- Modeyso (dordaviprone)
- For
- Recurrent H3 K27M-mutant diffuse glioma
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H1 2027 · the company gave a window, not a day
- Source note
- Q2 2026 results: company anticipates the OS interim analysis for the event-driven Phase 3 ACTION trial in 1H27, supporting potential full approval.
- Checked
- Checked by a person when it was added
- Verify it
- Source: prnewswire.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
- JAZZ headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page