Exelixis’ Advanced Cancer Drug Skips Advisory Committee Review
Exelixis, Inc. has received notification from the U.S. Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for their cancer treatment, cabozantinib (CABOMETYX®). The application, which seeks approval for treating adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic neuroendocrine tumors (epNET), will no longer be discussed at an Oncologic Drugs Advisory Committee meeting.
Despite this development, the FDA continues to evaluate the sNDA. The agency has set a Prescription Drug User Fee Act action date of April 3, 2025, by which time a decision on the application is expected.
Cabozantinib, already approved for certain types of kidney and liver cancers, could potentially expand its reach to patients with these rare but serious neuroendocrine tumors if the sNDA is approved.
Commentary by SuppBase columnist Alice Winters:
The FDA’s decision to forego an advisory committee meeting for Exelixis’ cabozantinib sNDA is a significant development in the realm of oncology treatments. This move could be interpreted in several ways, each with its own implications for patients, healthcare providers, and the pharmaceutical industry at large.
Firstly, the absence of an advisory committee review might suggest that the FDA sees the data supporting cabozantinib’s efficacy in treating pNET and epNET as sufficiently robust and straightforward. This could be a positive sign for Exelixis and for patients awaiting new treatment options. Neuroendocrine tumors, particularly those originating outside the pancreas, often have limited treatment options, making any potential new therapy a beacon of hope.
However, it’s crucial to temper optimism with caution. The FDA’s decision doesn’t guarantee approval, and the extended timeline (with an action date in 2025) suggests that the agency is taking its time to thoroughly review the application. This extended review period could be due to the complexity of the data, the rarity of the conditions being treated, or the need for additional information from the company.
From a market perspective, this development could be seen as a double-edged sword for Exelixis. On one hand, bypassing the advisory committee might accelerate the approval process if the FDA’s internal review is favorable. On the other hand, it deprives the company of a public forum to present its data and make its case directly to external experts, which can sometimes sway the FDA’s final decision.
For healthcare providers and patients, the potential expansion of cabozantinib’s indications to include pNET and epNET is noteworthy. Cabozantinib, a tyrosine kinase inhibitor, has shown promise in other solid tumors, and its potential efficacy in neuroendocrine tumors could offer a new weapon in the oncologist’s arsenal. However, it’s important to remember that even if approved, the drug’s real-world performance, side effect profile, and long-term outcomes will need careful monitoring.
The pharmaceutical industry will be watching this case closely, as it may set precedents for how the FDA handles applications for drugs seeking to expand into rare cancer indications. The outcome could influence future drug development strategies and regulatory approaches.
In conclusion, while the FDA’s decision to skip the advisory committee meeting for cabozantinib’s sNDA is intriguing, it’s just one step in a long and complex process. Stakeholders should remain cautiously optimistic while awaiting the FDA’s final decision in 2025. As always, the ultimate goal is to ensure that any approved treatments offer meaningful benefits to patients while maintaining a favorable safety profile.
