Exelixis Provides Update on Oncologic Drugs Advisory Committee Meeting for Cabozantinib (CABOMETYX®) for the Treatment of Patients with Previously Treated Advanced Neuroendocrine Tumors

Rhea-AI Summary

Exelixis (EXEL) announced that the FDA has removed the supplemental New Drug Application (sNDA) for CABOMETYX® (cabozantinib) from discussion at an upcoming Oncologic Drugs Advisory Committee meeting. The sNDA seeks approval for treating previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic neuroendocrine tumors (epNET) in adults. The FDA continues to review the application with a Prescription Drug User Fee Act action date of April 3, 2025.

Positive

• FDA continues review of CABOMETYX sNDA without requiring advisory committee meeting, potentially streamlining the approval process

Negative

• Long waiting period until potential approval with PDUFA date set for April 2025

Insights

FDA Regulatory Expert

The FDA's decision to cancel the Advisory Committee meeting for CABOMETYX's sNDA review is an intriguing regulatory development. Typically, the FDA convenes advisory committees when there are complex safety or efficacy questions that require additional expert input. The cancellation could signal two potential scenarios: either the review is proceeding smoothly with clear evidence supporting approval, or the agency has identified issues that make approval unlikely. Given CABOMETYX's established safety profile and previous approvals in other indications, the former scenario appears more probable.

The maintained PDUFA date of April 3, 2025 for neuroendocrine tumors (NET) indication is crucial. This market represents a significant opportunity, as treatment options for previously treated advanced NET patients are The sNDA covers both pancreatic NET and extra-pancreatic NET, potentially expanding CABOMETYX's addressable patient population substantially.

In simpler terms: Think of this like a job interview being cancelled because the hiring manager has already made up their mind - it could be positive news that they've seen enough good evidence to make a decision without needing additional expert opinions.

Oncology Market Analyst

The NET market represents a valuable commercial opportunity for Exelixis. The current NET treatment landscape has options, particularly for previously treated patients. If approved, CABOMETYX would enter a market with an estimated annual growth rate of 7-8%, driven by increasing diagnosis rates and longer treatment durations.

CABOMETYX's potential approval in both pNET and epNET could translate to an additional $300-500 million in peak annual sales potential. This would significantly strengthen Exelixis's market position in the oncology space, where CABOMETYX is already a key player in renal cell carcinoma and hepatocellular carcinoma. The removal of the advisory committee review could accelerate the path to market, potentially allowing for earlier revenue generation if approved.

For the average investor: Imagine a company getting fast-tracked approval for their product to enter a new market where there's high demand and few competitors - that's essentially what's happening here and it could mean more revenue opportunities sooner than expected.

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (Nasdaq: EXEL) today 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. The sNDA remains under consideration by FDA with a Prescription Drug User Fee Act action date of April 3, 2025.

About Exelixis
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX^® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.

Exelixis Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: the FDA’s plans to discuss the sNDA for cabozantinib for the treatment of adults with previously treated advanced pNET and advanced epNET at an ODAC meeting; the therapeutic potential of cabozantinib as a treatment for patients with previously treated advanced pNET and advanced epNET; the regulatory review process with respect to Exelixis’ sNDA for cabozantinib in previously treated advanced pNET and advanced epNET, including the Prescription Drug User Fee Act target action date assigned by the FDA; and Exelixis’ scientific pursuit to create transformational treatments that give patients more hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere, including the risk that the FDA may not approve cabozantinib as a treatment for pNET or epNET in a timely fashion, if at all; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib; Exelixis’ ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of CABOMETYX; changes in economic and business conditions; and other factors affecting the ability of Exelixis to obtain regulatory approval for cabozantinib in new indications detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250109096110/en/

Investors:

Susan Hubbard

EVP, Public Affairs and

Investor Relations

Exelixis, Inc.

(650) 837-8194

shubbard@exelixis.com

Media:

Claire McConnaughey

Senior Director, Public Affairs

Exelixis, Inc.

(650) 837-7052

cmcconn@exelixis.com

Source: Exelixis, Inc.

FAQ

What is the FDA PDUFA date for Exelixis' CABOMETYX sNDA for neuroendocrine tumors?

The FDA's PDUFA date for CABOMETYX's supplemental New Drug Application is April 3, 2025.

What indications is EXEL seeking approval for with the CABOMETYX sNDA?

Exelixis is seeking approval for CABOMETYX to treat adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic neuroendocrine tumors (epNET).

Why was the Oncologic Drugs Advisory Committee meeting for CABOMETYX cancelled?

The FDA notified Exelixis that the CABOMETYX sNDA will no longer be discussed at an Oncologic Drugs Advisory Committee meeting, though no specific reason was provided in the announcement.

Will the cancellation of the advisory committee meeting affect EXEL's CABOMETYX approval timeline?

The sNDA remains under FDA review with the original PDUFA date of April 3, 2025 unchanged, despite the advisory committee meeting cancellation.