Cabometyx sNDA Submitted for Expanded Renal Cell Carcinoma Indication
The sNDA is based on results from the Phase 2 CABOSUN trial
Exelixis has completed the submission of their supplemental New Drug Application (sNDA) for Cabometyx (cabozantinib) as a first line treatment for patients with previously untreated advanced renal cell carcinoma (RCC).
The sNDA submission includes results from CABOSUN, a Phase 2, open-label, active controlled trial. A total of 157 patients with previously untreated advanced RCC with intermediate- or poor-risk disease were enrolled and randomized 1:1 to receive cabozantinib (60mg once daily) or sunitinib (50mg once daily for 4 weeks followed by 2 weeks off) as first line therapies. The primary endpoint was progression-free survival (PFS).
Results showed that the cabozantinib group had significantly increased median PFS compared to the sunitinib group with 8.2 vs. 5.6 months, respectively. Additionally, the cabozantinib group was linked to a 34% reduction in rate of progression or death (adjusted HR 0.66; 95% CI: 0.46–0.95; P=0.012). Objective response rate (ORR) was 46% for the cabozantinib group vs. 18% for the sunitinib group.
Grade 3/4 adverse events were 67% for cabozantinib and 68% for sunitinib, and included diarrhea, fatigue, hypertension, palmar-plantar erythrodysesthesia, and hematologic adverse events.
Cabometyx works by inhibiting the activity of MET, AXL and VEGFR-1, -2 and -3 receptors. It was initially approved in 2016 by the Food and Drug Administration (FDA) to treat patients with advanced RCC in patients who have received prior anti-angiogenic therapy. Cabometyx is available as 20mg, 40mg or 60mg strength tablets.
For more information call (855) 500-3935 or visit Cabometyx.com.