EXEL Exelixis

Exelixis zanzalintinib NDA PDUFA extended to March 3, 2027 for mCRC

FDA extended the PDUFA target action date for the zanzalintinib + atezolizumab NDA in previously treated metastatic CRC by three months to March 3, 2027 after Exelixis submitted updated safety and efficacy data. The NDA is based on the phase 3 STELLAR-303 trial that met the OS primary endpoint in the ITT population.

zanzalintinib · NCT07489495 registry update

countries: {'total_sites': 103, 'us_sites': 9} → {'total_sites': 106, 'us_sites': 11}

zanzalintinib · NCT07049926 registry update

countries: {'total_sites': 32, 'us_sites': 7} → {'total_sites': 33, 'us_sites': 7}

zanzalintinib · NCT07489495 registry update

countries: {'total_sites': 101, 'us_sites': 7} → {'total_sites': 103, 'us_sites': 9}

zanzalintinib · NCT07489495 registry update

countries: {'total_sites': 99, 'us_sites': 6} → {'total_sites': 101, 'us_sites': 7}

zanzalintinib · NCT07428616 registry update

countries: {'total_sites': 17, 'us_sites': 17} → {'total_sites': 19, 'us_sites': 19}

zanzalintinib · NCT06943755 registry update

countries: {'total_sites': 126, 'us_sites': 40} → {'total_sites': 131, 'us_sites': 40}

zanzalintinib · NCT07489495 registry update

countries: {'total_sites': 90, 'us_sites': 4} → {'total_sites': 92, 'us_sites': 4}

zanzalintinib · NCT07750158 registry update

status: NOT_YET_RECRUITING → RECRUITING; countries: {'total_sites': 0, 'us_sites': 0} → {'total_sites': 13, 'us_sites': 13}

zanzalintinib · NCT07049926 registry update

countries: {'total_sites': 31, 'us_sites': 7} → {'total_sites': 32, 'us_sites': 7}

Exelixis: FDA sets Dec 3, 2026 PDUFA for zanzalintinib + atezolizumab in mCRC

FDA accepted the NDA for zanzalintinib plus atezolizumab in previously treated metastatic CRC and assigned a PDUFA target action date of December 3, 2026. The filing is based on the STELLAR-303 Phase 3 trial, which met its dual primary OS endpoint in the ITT population.

Exelixis: STELLAR-303 NLM OS endpoint not statistically significant

The final NLM-subgroup OS analysis showed a non-significant trend favoring zanzalintinib + atezolizumab (HR 0.83, P=0.1185). The ITT population had already met its dual-primary OS endpoint with statistical significance. The NDA for the combination remains under FDA review with a December 3, 2026 PDUFA date.

Exelixis: CABINET subgroup data at ASCO 2026 show cabozantinib PFS benefit in NET

The document reports that subgroup results from the Phase 3 CABINET trial will be presented at ASCO 2026, showing cabozantinib reduced risk of progression or death by 74% in non-functional NET and 60% in functional NET versus placebo. These data reinforce the drug’s approved use in previously treated advanced NET regardless of functional status.

Exelixis, Merck to supply KEYTRUDA QLEX for STELLAR-316 CRC trial

Exelixis and Merck entered a clinical development collaboration to supply KEYTRUDA QLEX for the planned Phase 3 STELLAR-316 trial. The trial will evaluate zanzalintinib with and without KEYTRUDA QLEX in resected stage II/III CRC patients who are MRD+. Exelixis expects to initiate the trial in mid-2026.

Exelixis: FDA accepts zanzalintinib NDA, sets PDUFA date Dec 3, 2026

FDA accepted Exelixis’ NDA for zanzalintinib plus atezolizumab in previously treated metastatic CRC and assigned a standard-review PDUFA target action date of December 3, 2026. The filing rests on positive STELLAR-303 Phase 3 OS data; the trial’s second dual-primary endpoint (OS in patients without liver metastases) is still pending.

Exelixis: STELLAR-303 final OS analysis (non-liver mets) mid-2026

The document states the STELLAR-303 final analysis of the second dual primary endpoint (OS in patients without liver metastases) is expected mid-2026. This is the next regulatory readout for the NDA already under FDA review for zanzalintinib + atezolizumab in previously treated CRC.