FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma
| Autor: | Chana Weinstock, Laleh Amiri-Kordestani, Xiao Hong Chen, Elaine Chang, Eias Zahalka, Jeanne Fourie Zirkelbach, Shenghui Tang, Amna Ibrahim, Mallorie H. Fiero, Julia A. Beaver, Kirsten B. Goldberg, Vishal Bhatnagar, Miao Zhao, Paul G. Kluetz, Richard Pazdur, Tiffany K. Ricks, Jingyu Yu, Junshan Qiu, Lijun Zhang |
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| Rok vydání: | 2022 |
| Předmět: |
Adult
Male Sorafenib Cancer Research medicine.medical_specialty Tivozanib Urology Administration Oral Article law.invention Randomized controlled trial law Renal cell carcinoma medicine Clinical endpoint Humans Adverse effect Carcinoma Renal Cell Drug Approval neoplasms Aged Randomized Controlled Trials as Topic Aged 80 and over business.industry Phenylurea Compounds Middle Aged medicine.disease Rash Kidney Neoplasms Discontinuation Survival Rate Treatment Outcome Oncology Quinolines Female Neoplasm Recurrence Local medicine.symptom business medicine.drug |
| Zdroj: | Clin Cancer Res |
| ISSN: | 1557-3265 1078-0432 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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