1. FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma.
- Author
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Chang E, Weinstock C, Zhang L, Fiero MH, Zhao M, Zahalka E, Ricks TK, Fourie Zirkelbach J, Qiu J, Yu J, Chen XH, Bhatnagar V, Goldberg KB, Tang S, Kluetz PG, Pazdur R, Ibrahim A, Beaver JA, and Amiri-Kordestani L
- Subjects
- Administration, Oral, Adult, Aged, Aged, 80 and over, Carcinoma, Renal Cell mortality, Female, Humans, Kidney Neoplasms mortality, Male, Middle Aged, Neoplasm Recurrence, Local, Phenylurea Compounds administration & dosage, Phenylurea Compounds adverse effects, Quinolines administration & dosage, Quinolines adverse effects, Randomized Controlled Trials as Topic, Sorafenib administration & dosage, Sorafenib therapeutic use, Survival Rate, Treatment Outcome, Carcinoma, Renal Cell drug therapy, Drug Approval, Kidney Neoplasms drug therapy, Phenylurea Compounds therapeutic use, Quinolines therapeutic use
- Abstract
On March 10, 2021, the FDA granted regular approval to tivozanib for treatment of patients with relapsed or refractory (R/R) advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. Approval was based on the TIVO-3 study, a randomized trial of tivozanib versus sorafenib in patients with R/R advanced RCC. In TIVO-3, patients were randomized to receive either tivozanib 1.34 mg orally once daily for 21 consecutive days of every 28-day cycle or sorafenib 400 mg orally twice daily continuously. The primary endpoint was progression-free survival (PFS) per RECIST v1.1. Tivozanib demonstrated efficacy compared with sorafenib with an improvement in PFS [HR, 0.73; 95% confidence interval (CI), 0.56-0.95; P = 0.016]. The estimated median PFS was 5.6 months and 3.9 months in the tivozanib and sorafenib arms, respectively. There was no evidence of a detrimental effect on overall survival: HR, 0.97 (95% CI, 0.75-1.24). The most common grade 3 to 4 adverse reaction on the tivozanib arm was hypertension (24%). Compared with sorafenib, tivozanib was associated with lower rates of grade 3 to 4 diarrhea, rash, and palmar-plantar erythrodysesthesia. Patients receiving tivozanib in TIVO-3 had lower rates of dose reduction, interruption, or permanent discontinuation than those receiving sorafenib., (©2021 American Association for Cancer Research.)
- Published
- 2022
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