This section highlights FDA-related milestones and regulatory updates for drugs developed by Exelixis (EXEL).
Over the past two years, Exelixis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CABOMETYX, cabozantinib, Cabozantinib, STELLAR-303, XL309, XL495, and Zanzalintinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CABOMETYX (cabozantinib) + OPDIVO (nivolumab) - FDA Regulatory Timeline and Events
CABOMETYX (cabozantinib) + OPDIVO (nivolumab) is a drug developed by Exelixis for the following indication: Unresectable or Metastatic Renal Cell Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CABOMETYX (cabozantinib) + OPDIVO (nivolumab)
- Announced Date:
- February 15, 2025
- Indication:
- Unresectable or Metastatic Renal Cell Carcinoma
Announcement
Exelixis, Inc announced final results from the phase 3 CheckMate -9ER pivotal trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) versus sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC).
AI Summary
Exelixis, Inc. announced the final results from its phase 3 CheckMate‑9ER pivotal trial comparing CABOMETYX® (cabozantinib) combined with Opdivo® (nivolumab) to sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC). After more than five years of follow‐up, the combination therapy demonstrated a lasting survival benefit over sunitinib. The trial showed that patients receiving CABOMETYX plus Opdivo experienced improved progression‐free survival, with a hazard ratio of 0.58, and overall survival, with a hazard ratio of 0.79. Additionally, subgroup analyses revealed that the long-term efficacy was maintained regardless of metastases location, including liver, bone, and lung. These positive findings support the use of the CABOMETYX and Opdivo regimen as a valuable first-line treatment option, offering durable clinical benefits for patients with advanced RCC.
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cabozantinib - FDA Regulatory Timeline and Events
cabozantinib is a drug developed by Exelixis for the following indication: For neuroendocrine tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- cabozantinib
- Announced Date:
- June 20, 2025
- Indication:
- For neuroendocrine tumors
Announcement
Exelixis, Inc announced that its partner Ipsen received a positive opinion from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for CABOMETYX® (cabozantinib) for adult patients with unresectable or metastatic, well-differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues.
AI Summary
Exelixis announced that its partner Ipsen received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for CABOMETYX® (cabozantinib). This recommendation supports its use in adult patients with unresectable or metastatic, well-differentiated extra-pancreatic and pancreatic neuroendocrine tumors who have progressed after at least one prior systemic therapy (excluding somatostatin analogues).
The positive opinion is based on data from the Phase 3 CABINET pivotal trial, which showed that cabozantinib improved outcomes compared to placebo in patients with these tumor types. The next step is for the European Commission to review the recommendation, with a final decision expected in the coming months. This progress marks a significant milestone in expanding treatment options for patients with these challenging cancers.
Read Announcement - Drug:
- cabozantinib
- Announced Date:
- March 26, 2025
- Indication:
- For neuroendocrine tumors
Announcement
Exelixis, Inc announced that the U.S. Food and Drug Administration (FDA) has approved CABOMETYX® (cabozantinib) for the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET); and 2) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET).
AI Summary
Exelixis announced that the U.S. FDA has approved CABOMETYX (cabozantinib) for use in adult and pediatric patients 12 years and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated neuroendocrine tumors. The approval covers two groups: one for pancreatic neuroendocrine tumors (pNET) and another for extra-pancreatic NET (epNET). This decision is supported by the phase 3 CABINET trial, which showed a statistically significant improvement in progression-free survival compared to a placebo. With this approval, CABOMETYX becomes the first and only systemic treatment available for NET regardless of primary tumor site, grade, somatostatin receptor expression, or functional status. Exelixis is now ready to immediately support these new treatment indications, offering a meaningful new option for patients with advanced neuroendocrine tumors.
Read Announcement- Drug:
- cabozantinib
- Announced Date:
- January 24, 2025
- Indication:
- For neuroendocrine tumors
Announcement
Exelixis, Inc announced results from a subgroup analysis of the phase 3 CABINET pivotal study of patients with extra-pancreatic neuroendocrine tumors (epNET) arising in the gastrointestinal (GI) tract.
AI Summary
Exelixis, Inc. announced promising findings from a subgroup analysis of the phase 3 CABINET study that focused on patients with extra-pancreatic neuroendocrine tumors (epNET) in the gastrointestinal (GI) tract. The analysis revealed that cabozantinib reduced the risk of disease progression or death by 50% compared to a placebo. In this study subgroup of 116 patients, the median progression-free survival was 8.5 months with cabozantinib versus 5.6 months with placebo.
These results suggest that cabozantinib may help delay tumor growth and improve outcomes in patients with advanced GI neuroendocrine tumors—a group with limited treatment options. The findings, presented at a major oncology conference, provide new insights into how this treatment could offer significant benefits to patients facing this challenging condition.
Read Announcement- Drug:
- cabozantinib
- Announced Date:
- November 26, 2024
- Indication:
- For neuroendocrine tumors
Announcement
Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025.
AI Summary
The FDA has informed Exelixis that its supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. This sNDA is for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic neuroendocrine tumors (epNET) and is supported by final results from the phase 3 CABINET trial.
The CABINET study demonstrated a significant improvement in progression-free survival for patients compared to placebo. The upcoming ODAC meeting will focus on evaluating the safety and effectiveness of cabozantinib based on these findings, aiming to determine if it can be used as a new treatment option for aggressive neuroendocrine tumors. This step marks an important part of Exelixis’ efforts to expand the clinical uses of CABOMETYX and provide additional hope for patients facing challenging cancers.
Read Announcement- Drug:
- cabozantinib
- Announced Date:
- September 15, 2024
- Indication:
- For neuroendocrine tumors
Announcement
Exelixis, Inc. announced detailed final overall survival (OS) results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (Tecentriq®) compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT.
AI Summary
Exelixis, Inc. announced detailed final overall survival (OS) results from the CONTACT-02 phase 3 study, which evaluated the combination of cabozantinib (CABOMETYX®) with atezolizumab (Tecentriq®) versus a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC). The trial focused on patients with measurable extra-pelvic soft tissue disease who had progressed on one prior NHT. At a median follow-up of 24 months, the OS analysis showed a numerical improvement (hazard ratio of 0.89), though it did not reach statistical significance. Notably, the subgroup of patients with liver metastases showed a significant OS benefit. These findings suggest that the combination regimen could be beneficial for patients with advanced prostate cancer by potentially delaying disease progression in a population with limited treatment options.
Read Announcement- Drug:
- cabozantinib
- Announced Date:
- August 6, 2024
- Indication:
- For neuroendocrine tumors
Announcement
Exelixis, Inc announced that its supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) has been accepted in the U.S.
AI Summary
Exelixis, Inc. announced that its supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) has been accepted by the FDA in the United States. The application targets adults with previously treated, locally advanced or metastatic, well- or moderately differentiated pancreatic and extra-pancreatic neuroendocrine tumors (pNET and epNET). The submission is based on results from the phase 3 CABINET pivotal trial, which showed a significant improvement in progression-free survival compared to placebo. Additionally, cabozantinib has received orphan drug designation for treating pNET. The FDA has set a Prescription Drug User Fee Act target action date of April 3, 2025, and will conduct a standard review. Exelixis expressed gratitude for the opportunity to work with the FDA and hopes to offer a new treatment option for patients facing limited choices for difficult-to-treat cancers.
Read Announcement- Drug:
- cabozantinib
- Announced Date:
- August 6, 2024
- Estimated Event Date Range:
- April 3, 2025 - April 3, 2025
- Target Action Date:
- April 3, 2025
- Indication:
- For neuroendocrine tumors
Announcement
Exelixis, Inc. announced that The FDA assigned a standard review with a Prescription Drug User Fee Act target action date of April 3, 2025.
AI Summary
Exelixis, Inc. announced that the FDA has accepted its supplemental New Drug Application (sNDA) for cabozantinib, a treatment aimed at adults with advanced pancreatic and extra-pancreatic neuroendocrine tumors. The application is supported by promising data from the phase 3 CABINET trial, which showed a significant and meaningful improvement in progression-free survival for patients compared to a placebo.
The FDA has designated a standard review for the sNDA, and a Prescription Drug User Fee Act target action date has been set for April 3, 2025. This decision represents an important milestone in Exelixis' commitment to expanding treatment options for patients with challenging neuroendocrine cancers and highlights ongoing efforts to provide effective therapies to those with limited alternatives.
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Cabozantinib (CABOMETYX) - FDA Regulatory Timeline and Events
Cabozantinib (CABOMETYX) is a drug developed by Exelixis for the following indication: Differentiated thyroid cancer (DTC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cabozantinib (CABOMETYX)
- Announced Date:
- January 9, 2025
- Indication:
- Differentiated thyroid cancer (DTC)
Announcement
Exelixis, Inc. announced it has been notified by the U.S. Food and Drug Administration (FDA) that the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic (epNET) will no longer be the subject of discussion at an Oncologic Drugs Advisory Committee meeting.
AI Summary
Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) will no longer discuss the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) at an Oncologic Drugs Advisory Committee meeting. The sNDA is for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic neuroendocrine tumors (epNET).
Despite the change in the meeting format, the FDA is still considering the application. The agency has set a Prescription Drug User Fee Act action date for April 3, 2025. Exelixis remains focused on the potential of cabozantinib and continues to support its efforts to offer new treatment options for cancer patients.
Read Announcement- Drug:
- Cabozantinib (CABOMETYX)
- Announced Date:
- January 9, 2025
- Estimated Event Date Range:
- April 3, 2025 - April 3, 2025
- Target Action Date:
- April 3, 2025
- Indication:
- Differentiated thyroid cancer (DTC)
Announcement
Exelixis, Inc announced that The sNDA remains under consideration by FDA with a Prescription Drug User Fee Act action date of April 3, 2025.
AI Summary
Exelixis, Inc. announced that its supplemental New Drug Application (sNDA) for cabozantinib remains under FDA review. The application targets the use of CABOMETYX® for treating adults with advanced pancreatic and extra-pancreatic neuroendocrine tumors who have already received treatment. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2025, which is the target date for making a decision on this application. Exelixis is focused on advancing new treatment options for cancer patients through its innovative research and development program. This ongoing review demonstrates the company’s commitment to bringing novel and effective therapies to market, aiming to improve the treatment outcomes and quality of life for patients facing challenging cancers.
Read Announcement- Drug:
- Cabozantinib (CABOMETYX)
- Announced Date:
- September 16, 2024
- Indication:
- Differentiated thyroid cancer (DTC)
Announcement
Exelixis, Inc announced updated and final data from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) versus placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort with advanced pancreatic neuroendocrine tumors (pNET) and one cohort with advanced extra-pancreatic NET (epNET).
AI Summary
Exelixis, Inc. announced final and updated results from the phase 3 CABINET trial, which evaluated cabozantinib (CABOMETYX®) versus placebo in patients with previously treated advanced neuroendocrine tumors. The trial included two cohorts: one with advanced pancreatic neuroendocrine tumors (pNET) and one with advanced extra-pancreatic NET (epNET). In the pNET cohort, patients treated with cabozantinib had a median progression-free survival (PFS) of 13.8 months compared to 4.4 months for placebo. Similarly, in the epNET group, the median PFS was 8.4 months with cabozantinib versus 3.9 months with placebo. These significant improvements in PFS were observed across major clinical subgroups and have supported a supplemental new drug application with the FDA. The findings indicate that cabozantinib could become a new standard treatment option for patients with advanced neuroendocrine tumors.
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STELLAR-303 - FDA Regulatory Timeline and Events
STELLAR-303 is a drug developed by Exelixis for the following indication: In Patients with Metastatic Colorectal Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- STELLAR-303
- Announced Date:
- June 22, 2025
- Indication:
- In Patients with Metastatic Colorectal Cancer
Announcement
Exelixis, Inc. announced positive topline results from the STELLAR-303 phase 3 pivotal trial in which zanzalintinib in combination with atezolizumab (Tecentriq®) demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intent-to-treat (ITT) population of patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (CRC).
AI Summary
Exelixis, Inc. announced top-line results from its phase 3 STELLAR-303 trial, demonstrating that the combination of zanzalintinib and atezolizumab (Tecentriq®) significantly improved overall survival compared to regorafenib. This improvement was observed in the intent-to-treat population of patients with previously treated non-microsatellite instability-high metastatic colorectal cancer. An independent data monitoring committee conducted the final analysis on one of the dual primary endpoints, and the promising results mark a key milestone in the development of zanzalintinib.
The safety profile for the zanzalintinib plus atezolizumab combination was consistent with previous observations, with no new safety signals emerging. Exelixis plans to discuss these findings with regulatory authorities and will present additional detailed results at an upcoming medical conference.
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XL309 - FDA Regulatory Timeline and Events
XL309 is a drug developed by Exelixis for the following indication: USP1 inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XL309
- Announced Date:
- March 25, 2025
- Indication:
- USP1 inhibitor
Announcement
Exelixis, Inc. announced that preclinical data will be presented for four pipeline molecules at the American Association for Cancer Research (AACR) Annual Meeting 2025 taking place April 25-30 in Chicago, IL.
AI Summary
Exelixis, Inc. announced that preclinical data for four promising pipeline molecules will be presented at the AACR Annual Meeting 2025 in Chicago, IL, from April 25-30. The company will showcase two small molecule candidates, XL495 and XL309, that have shown potential to trigger cell death in tumors with certain genetic anomalies. Additionally, Exelixis will present data on two biotherapeutic candidates—a PD-L1 x NKG2A bispecific antibody named XB628 and a tissue factor-targeting antibody-drug conjugate, XB371. The results from these studies suggest that the molecules could advance into clinical development and may lead to best- and first-in-class therapies for patients with advanced solid tumors. This presentation supports Exelixis’s ongoing commitment to developing innovative cancer treatments and furthering the scientific understanding of potential new therapeutic options.
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XL495 - FDA Regulatory Timeline and Events
XL495 is a drug developed by Exelixis for the following indication: inhibitor of PKMYT1.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XL495
- Announced Date:
- March 25, 2025
- Indication:
- inhibitor of PKMYT1
Announcement
Exelixis, Inc. announced that preclinical data will be presented for four pipeline molecules at the American Association for Cancer Research (AACR) Annual Meeting 2025 taking place April 25-30 in Chicago, IL.
AI Summary
Exelixis, Inc. announced that preclinical data for four key pipeline molecules will be presented at the AACR Annual Meeting 2025 in Chicago, Illinois, from April 25-30. This preclinical research highlights the development of innovative treatment candidates for patients with advanced solid tumors. The data includes information on two small molecules and two biotherapeutic agents. The small molecules, which have shown synthetic lethality in certain genetic contexts, have the potential to be best- or first-in-class therapies. Additionally, the biotherapeutic candidates—one being a PD-L1xNKG2A-targeting bispecific antibody and the other an antibody-drug conjugate targeting tissue factor—suggest promising avenues for improved cancer treatment. The findings from these studies support further clinical development and signal the company’s commitment to advancing novel cancer therapies through rigorous research and regulatory pathways.
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Zanzalintinib - FDA Regulatory Timeline and Events
Zanzalintinib is a drug developed by Exelixis for the following indication: For Advanced Kidney Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zanzalintinib
- Announced Date:
- January 25, 2025
- Indication:
- For Advanced Kidney Cancer
Announcement
Exelixis, Inc announced results from an expansion cohort of the phase 1b/2 STELLAR-001 trial evaluating zanzalintinib alone or in combination with atezolizumab (Tecentriq®) in patients with previously-treated metastatic colorectal cancer (CRC).
AI Summary
Exelixis, Inc. announced promising findings from an expansion cohort of the phase 1b/2 STELLAR-001 trial, which looked at zanzalintinib alone versus zanzalintinib combined with atezolizumab in patients with previously treated metastatic colorectal cancer. The study involved 107 patients who had already undergone multiple therapies. In a subgroup analysis, patients without liver metastases experienced notably better results with the combination treatment. These patients showed longer periods without tumor growth, as well as improved overall survival compared to those who received only zanzalintinib. The results suggest that adding atezolizumab may enhance the effectiveness of zanzalintinib, especially in patients who do not have liver metastases. These findings have encouraged further research, including a planned phase 3 trial (STELLAR-303), which will compare the combination treatment with another treatment option, regorafenib, to potentially offer better care for these patients.
Read Announcement
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