title: U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma.
abstract: On April 25, 2016, the FDA approved cabozantinib (Cabometyx; Exelixis, Inc.) for the treatment of advanced renal cell carcinoma (RCC) in patients who have received prior antiangiogenic therapy. The approval was based on data from one randomized, open-label, multicenter study in which patients with RCC who had received prior antiangiogenic therapy were treated with either cabozantinib 60 mg orally once daily (n = 330) or everolimus 10 mg orally once daily (n = 328). The major efficacy outcome measure was progression-free survival (PFS) as assessed by a blinded independent radiology review committee in the first 375 randomized patients. A statistically significant improvement in PFS was seen, with a median PFS of 7.4 and 3.8 months in the cabozantinib and everolimus arms, respectively [hazard ratio (HR), 0.58; 95% confidence interval (CI), 0.45-0.74; P < 0.0001]. At a second interim analysis, a statistically significant improvement in overall survival (OS) in the intent-to-treat population was also demonstrated, with a median OS of 21.4 and 16.5 months in the cabozantinib and everolimus arms, respectively (HR, 0.66; 95% CI, 0.53-0.83; P = 0.0003). The most common (greater than or equal to 25%) adverse reactions included diarrhea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, hypertension, vomiting, weight loss, and constipation. Clin Cancer Res; 23(2); 330-5. ©2016 AACR.
authors: U.S. Food and Drug Administration, White Oak, Maryland. Harpreet.Singh@fda.hhs.gov.
authors: Harpreet
authors: H
authors: Singh
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Michael
authors: M
authors: Brave
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Julia A
authors: JA
authors: Beaver
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Joyce
authors: J
authors: Cheng
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Shenghui
authors: S
authors: Tang
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Eias
authors: E
authors: Zahalka
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Todd R
authors: TR
authors: Palmby
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Rajesh
authors: R
authors: Venugopal
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Pengfei
authors: P
authors: Song
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Qi
authors: Q
authors: Liu
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Chao
authors: C
authors: Liu
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Jingyu
authors: J
authors: Yu
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Xiao Hong
authors: XH
authors: Chen
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Xing
authors: X
authors: Wang
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Yaning
authors: Y
authors: Wang
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Paul G
authors: PG
authors: Kluetz
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Selena R
authors: SR
authors: Daniels
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Elektra J
authors: EJ
authors: Papadopoulos
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Rajeshwari
authors: R
authors: Sridhara
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Amy E
authors: AE
authors: McKee
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Amna
authors: A
authors: Ibrahim
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Geoffrey
authors: G
authors: Kim
authors: U.S. Food and Drug Administration, White Oak, Maryland.
authors: Richard
authors: R
authors: Pazdur
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000813:Anilides / Q000008:administration & dosage* / Q000009:adverse effects; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D020533:Angiogenesis Inhibitors; D000813:Anilides; D047428:Protein Kinase Inhibitors; D011725:Pyridines; C558660:cabozantinib