News
October 21, 2025
Exelixis plans NDA for zanzalintinib on colorectal cancer data
Much-awaited detailed data from Exelixis Inc.’s phase III Stellar-303 study of zanzalintinib, presented at the European Society for Medical Oncology meeting, showed the third-generation, oral tyrosine kinase inhibitor in combination with Tecentriq (atezolizumab, Roche AG) reduced the risk of death by 20% vs. Stivarga (regorafenib, Bayer AG) in patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer and are expected to pave the way for an NDA filing later this year.
**Exelixis Gears Up for FDA Submission of New Colorectal Cancer Treatment**
Exelixis Inc. is preparing to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug, zanzalintinib, following promising results from a late-stage clinical trial. The data, unveiled at the recent European Society for Medical Oncology (ESMO) meeting, showcases the potential of zanzalintinib in treating a specific type of advanced colorectal cancer.
The study, known as Stellar-303, focused on patients with metastatic colorectal cancer who had already undergone previous treatments and whose tumors were classified as non-microsatellite instability high (MSI-high). These patients often face limited treatment options, making the findings particularly significant.
Zanzalintinib is a third-generation, oral tyrosine kinase inhibitor. These inhibitors work by targeting specific proteins within cancer cells that help them grow and spread. In the Stellar-303 trial, zanzalintinib was administered in combination with Tecentriq (atezolizumab), an immunotherapy drug developed by Roche AG.
The results demonstrated a statistically significant improvement in overall survival for patients receiving the zanzalintinib and Tecentriq combination compared to those treated with Stivarga (regorafenib), a standard treatment option manufactured by Bayer AG. Specifically, the combination therapy reduced the risk of death by 20% compared to Stivarga.
This improvement in survival is a crucial development in the treatment landscape for this challenging disease. Colorectal cancer remains a leading cause of cancer-related deaths worldwide, and new therapies are urgently needed to improve patient outcomes.
Exelixis anticipates submitting the NDA to the FDA later this year, based on the strength of the Stellar-303 data. If approved, zanzalintinib could offer a valuable new treatment option for patients with previously treated non-MSI-high metastatic colorectal cancer, providing hope for improved survival and quality of life. The company will be working closely with regulatory agencies to ensure a smooth and timely review process. The presentation of this data at ESMO has generated considerable excitement within the oncology community, highlighting the potential of zanzalintinib to address an unmet medical need.
Exelixis Inc. is preparing to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug, zanzalintinib, following promising results from a late-stage clinical trial. The data, unveiled at the recent European Society for Medical Oncology (ESMO) meeting, showcases the potential of zanzalintinib in treating a specific type of advanced colorectal cancer.
The study, known as Stellar-303, focused on patients with metastatic colorectal cancer who had already undergone previous treatments and whose tumors were classified as non-microsatellite instability high (MSI-high). These patients often face limited treatment options, making the findings particularly significant.
Zanzalintinib is a third-generation, oral tyrosine kinase inhibitor. These inhibitors work by targeting specific proteins within cancer cells that help them grow and spread. In the Stellar-303 trial, zanzalintinib was administered in combination with Tecentriq (atezolizumab), an immunotherapy drug developed by Roche AG.
The results demonstrated a statistically significant improvement in overall survival for patients receiving the zanzalintinib and Tecentriq combination compared to those treated with Stivarga (regorafenib), a standard treatment option manufactured by Bayer AG. Specifically, the combination therapy reduced the risk of death by 20% compared to Stivarga.
This improvement in survival is a crucial development in the treatment landscape for this challenging disease. Colorectal cancer remains a leading cause of cancer-related deaths worldwide, and new therapies are urgently needed to improve patient outcomes.
Exelixis anticipates submitting the NDA to the FDA later this year, based on the strength of the Stellar-303 data. If approved, zanzalintinib could offer a valuable new treatment option for patients with previously treated non-MSI-high metastatic colorectal cancer, providing hope for improved survival and quality of life. The company will be working closely with regulatory agencies to ensure a smooth and timely review process. The presentation of this data at ESMO has generated considerable excitement within the oncology community, highlighting the potential of zanzalintinib to address an unmet medical need.
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