FDA Updates EXEL on Previously Scheduled ODAC Meeting for Cabozantinib

FDA Update on Cabozantinib sNDA - The FDA notified Exelixis about an update to its supplemental new drug application (sNDA) for cabozantinib, seeking approval for treating adults with advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) [1] - The sNDA was initially scheduled for discussion at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025 but will no longer be discussed, with a target action date of April 3, 2025 [2] - The sNDA is based on the final results of the phase III CABINET pivotal trial, which evaluated cabozantinib versus placebo in advanced pNET and epNET [11] Clinical Trial Results and Orphan Drug Designation - The CABINET trial showed substantial improvement in progression-free survival (PFS), leading to the recommendation to stop enrollment and unblind patients to allow crossover from placebo to cabozantinib [3] - Final results confirmed statistically significant and clinically meaningful improvements in PFS with cabozantinib versus placebo [8] - The FDA granted cabozantinib orphan drug designation for the treatment of pNET in August 2024 [4] Cabometyx Sales and Pipeline Expansion - Exelixis generated $1.3 billion in product revenues in the first nine months of 2024, primarily from Cabometyx sales [9] - The company is working to expand the Cabometyx label and diversify its oncology portfolio beyond Cabometyx [9] - Another promising candidate, zanzalintinib, is being evaluated in late-stage studies for metastatic refractory colorectal cancer, with preliminary results expected in 2025 [13] Collaboration with Merck - Exelixis is collaborating with Merck to evaluate zanzalintinib in combination with Keytruda for head and neck squamous cell carcinoma (HNSCC) and with Welireg for renal cell carcinoma (RCC) [5] - Merck will supply Keytruda for the phase III STELLAR-305 study in previously untreated PD-L1-positive recurrent or metastatic HNSCC [10] Stock Performance and Industry Comparison - Exelixis' shares have gained 53.2% in the past six months, outperforming the industry's decline of 10.1% [7] - The company currently carries a Zacks Rank 2 (Buy), while other top-ranked biotech stocks include Immunocore Holdings plc (IMCR) and Castle Biosciences, Inc. (CSTL), both with a Zacks Rank 1 (Strong Buy) [6]