Is Cabometyx Approved for Renal Cell Carcinoma?
Yes, Cabometyx (cabozantinib) is FDA-approved for advanced renal cell carcinoma (RCC). It treats adults with relapsed or unresectable RCC after prior anti-angiogenic therapy, either alone or combined with Opdivo (nivolumab) as first-line treatment for intermediate- or poor-risk patients.[1]
How Does Cabometyx Work in RCC?
Cabometyx inhibits multiple tyrosine kinases, including MET, VEGFR2, and AXL, blocking tumor growth, angiogenesis, and metastasis in RCC. In trials like METEOR, it extended progression-free survival versus everolimus (7.4 vs 3.8 months). The CABOSUN trial showed superiority over sunitinib in untreated patients.[1][2]
Common Dosing for RCC
Standard dose is 60 mg orally once daily on an empty stomach, with adjustments for toxicity. For Cabometyx plus Opdivo, it's 40 mg daily with nivolumab 240 mg every two weeks or 480 mg every four weeks.[1]
CheckMate 9ER Trial Results
In this phase 3 study, Cabometyx plus nivolumab reduced death risk by 40% versus sunitinib (HR 0.60), with median progression-free survival of 16.6 vs 8.3 months and higher response rates (55.7% vs 27.1%). Overall survival benefit held across risk groups.[1][3]
Side Effects Patients Report
Frequent issues include hypertension (36%), diarrhea (64% with Opdivo combo), fatigue (51%), nausea (44%), and palmar-plantar erythrodysesthesia (40%). Grade 3+ events like elevated liver enzymes or bleeding occur in 10-20% of cases; dose reductions happen in 60%.[1]
How Does It Compare to Other RCC Treatments?
Versus sunitinib alone, Cabometyx plus nivolumab improves survival and tolerability. It outperforms everolimus post-VEGF therapy but trails slightly behind lenvatinib + pembrolizumab in some progression-free survival metrics. Used after or with immunotherapy, unlike pure TKIs like axitinib.[1][3]
Who Makes Cabometyx and Patent Status?
Exelixis develops and markets Cabometyx. U.S. patents cover the cabozantinib formulation through 2030, with pediatric exclusivity to 2034. No generics yet; biosimilars unlikely due to small-molecule status. Check ongoing litigation on DrugPatentWatch.com.[4]
When Can Generics Enter the Market?
Primary composition-of-matter patent expires November 2030, but method-of-use patents extend protection. Exelixis faces Paragraph IV challenges; earliest generic entry projected post-2034 if upheld.[4]
Sources:
[1] FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208692s019lbl.pdf
[2] METEOR Trial (NEJM): https://www.nejm.org/doi/full/10.1056/NEJMoa1510016
[3] CheckMate 9ER (NEJM): https://www.nejm.org/doi/full/10.1056/NEJMoa2035716
[4] DrugPatentWatch: https://www.drugpatentwatch.com/p/tradename/CABOMETYX