PDUFA date for zanzalintinib + atezolizumab in metastatic colorectal cancer
The FDA is due to decide by Dec 3, 2026 whether to approve Exelixis’ Zanzalintinib (+ atezolizumab) for Previously treated non-MSI-high metastatic colorectal cancer. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Exelixis, Inc. EXEL
- Drug
- Zanzalintinib (+ atezolizumab)
- For
- Previously treated non-MSI-high metastatic colorectal cancer
- Stage
- NDA under FDA review (standard review)
- When
- Dec 3, 2026
- Source note
- FDA accepted the NDA in February 2026 with a PDUFA target action date of December 3, 2026, based on STELLAR-303, which showed a statistically significant overall survival benefit vs regorafenib.
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- Checked by a person when it was added
- Source: biospace.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
- EXEL headlines on this site
Exelixis expects to report results from its Phase 3 study of Zanzalintinib (+ nivolumab) for Previously untreated advanced non-clear cell renal cell carcinoma 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
- STELLAR-304 Phase 3 topline in non-clear cell RCC · Clinical trial results (readout / topline data)
- Drug
- Zanzalintinib (+ nivolumab)
- For
- Previously untreated advanced non-clear cell renal cell carcinoma
- 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
- Exelixis Q2 2026 earnings release (Aug 5, 2026): topline results expected in the second half of 2026, timing dependent on event rates; primary endpoints PFS (BIRC) and ORR vs sunitinib.
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- Checked by a person when it was added
- Verify it
- Source: biospace.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
- EXEL headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Zanzalintinib Phase 2 STELLAR-202 squamous NSCLC initiation, expected in the second half of 2026 (no exact date yet). A company milestone for Exelixis (zanzalintinib for Squamous non-small cell lung cancer): a step in the program rather than a decision or a data readout.
More details
- Entry
- Zanzalintinib Phase 2 STELLAR-202 squamous NSCLC initiation · Company milestone
- Drug
- zanzalintinib
- For
- Squamous non-small cell lung cancer
- 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
- Q2 2026 earnings PR (Aug 4, 2026).
- Checked
- Checked by a person when it was added
- Verify it
- Source: finance.yahoo.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
- EXEL headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page