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On March 10, 2021, tivozanib was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC).
This approval is mainly based on the results of the Phase III TIVO-3 study [1].
Renal cell carcinoma is a highly malignant tumor in the urinary system and one of the most common refractory malignancies, accounting for 80%-90% of renal malignancies.
The emergence of molecularly targeted drugs has made the treatment of renal cell carcinoma more targeted.
Vascular endothelial growth factor receptor (VEGFR) is an effective target for the treatment of metastatic renal cell carcinoma.
VEGFR inhibitors are more effective in such patients.
Good anti-tumor activity.
Tivozanib is a potent, highly selective, oral VEGFR tyrosine kinase inhibitor (TKI).
This approval is mainly based on the Phase III TIVO-3 study.
This is a multi-center, open-label phase III randomized controlled study.
350 patients with highly refractory metastatic renal cell carcinoma who failed at least two lines of treatment were randomly assigned to receive tivozanib or sorafenib in a 1:1 ratio.
treatment.
Past results have shown that compared with sorafenib, tivozanib can significantly improve the progression-free survival (PFS) of patients with relapsed or refractory renal cell carcinoma.
The median PFS of the Tivozanib group and Sorafenib group were 5.
6 months and 3.
9 months, respectively (HR=0.
73, P=0.
016).
The updated data showed that at a median follow-up of 38 months, the median OS of the tivozanib group and sorafenib group were 16.
4 months and 19.
2 months, respectively.Subgroup analysis showed that patients who previously received immune checkpoint inhibitors (HR=0.
55) and VEGF inhibitors (HR=0.
57) benefited the most from tivozanib treatment [2].
18% and 8% of patients in the Tivozanib group and Sorafenib group achieved partial remission, respectively, and the objective response rate (ORR) was 34% and 24%, respectively.
Tivozanib was well tolerated, and the most common grade 3 or 4 adverse event in the tivozanib group and sorafenib group was hypertension (21% vs 14%).
The most common adverse events of any grade in the Tivozanib group included hypertension (38%), diarrhea (33%), fatigue (29%), and decreased appetite (27%).
The principal investigator, Dr.
Brian Rini of Vanderbilt Ingram Cancer Center, pointed out that the approval of tivozanib provides a new treatment option for the second-line and above treatment of renal cell carcinoma patients.
As the treatment of renal cell carcinoma progresses, the survival time of patients is also prolonged.
In relapsed or refractory patients, new and validated and well-tolerated treatment options are needed.
The TIVO-3 study is the first phase III study to show positive results in the second-line and above treatment of renal cell carcinoma, and it is also the first phase III study conducted in a pre-set population that has progressed after receiving first-line standard immunotherapy.
This approval makes Tivozanib a powerful treatment plan, and it is expected that Tivozanib can play a clinically significant role in the treatment of renal cell carcinoma.
References: [1] AVEO Oncology Announces US FDA Approval of FOTIVDA® (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma.
AVEO Oncology.
News release.
March 10, 2021.
Accessed March 10, 2021.
[2]Pal SK, Escudier B, Atkins MB, et al.
TIVO-3: Final OS analysis of a phase III, randomized, controlled, multicenter, open-label study to compare tivozanib to sorafenib in subjects with metastatic renal cell carcinoma ( RCC).
Presented at: 2020 ASCO Virtual Program; May 27, 2020.
Abstract 5062.
This approval is mainly based on the results of the Phase III TIVO-3 study [1].
Renal cell carcinoma is a highly malignant tumor in the urinary system and one of the most common refractory malignancies, accounting for 80%-90% of renal malignancies.
The emergence of molecularly targeted drugs has made the treatment of renal cell carcinoma more targeted.
Vascular endothelial growth factor receptor (VEGFR) is an effective target for the treatment of metastatic renal cell carcinoma.
VEGFR inhibitors are more effective in such patients.
Good anti-tumor activity.
Tivozanib is a potent, highly selective, oral VEGFR tyrosine kinase inhibitor (TKI).
This approval is mainly based on the Phase III TIVO-3 study.
This is a multi-center, open-label phase III randomized controlled study.
350 patients with highly refractory metastatic renal cell carcinoma who failed at least two lines of treatment were randomly assigned to receive tivozanib or sorafenib in a 1:1 ratio.
treatment.
Past results have shown that compared with sorafenib, tivozanib can significantly improve the progression-free survival (PFS) of patients with relapsed or refractory renal cell carcinoma.
The median PFS of the Tivozanib group and Sorafenib group were 5.
6 months and 3.
9 months, respectively (HR=0.
73, P=0.
016).
The updated data showed that at a median follow-up of 38 months, the median OS of the tivozanib group and sorafenib group were 16.
4 months and 19.
2 months, respectively.Subgroup analysis showed that patients who previously received immune checkpoint inhibitors (HR=0.
55) and VEGF inhibitors (HR=0.
57) benefited the most from tivozanib treatment [2].
18% and 8% of patients in the Tivozanib group and Sorafenib group achieved partial remission, respectively, and the objective response rate (ORR) was 34% and 24%, respectively.
Tivozanib was well tolerated, and the most common grade 3 or 4 adverse event in the tivozanib group and sorafenib group was hypertension (21% vs 14%).
The most common adverse events of any grade in the Tivozanib group included hypertension (38%), diarrhea (33%), fatigue (29%), and decreased appetite (27%).
The principal investigator, Dr.
Brian Rini of Vanderbilt Ingram Cancer Center, pointed out that the approval of tivozanib provides a new treatment option for the second-line and above treatment of renal cell carcinoma patients.
As the treatment of renal cell carcinoma progresses, the survival time of patients is also prolonged.
In relapsed or refractory patients, new and validated and well-tolerated treatment options are needed.
The TIVO-3 study is the first phase III study to show positive results in the second-line and above treatment of renal cell carcinoma, and it is also the first phase III study conducted in a pre-set population that has progressed after receiving first-line standard immunotherapy.
This approval makes Tivozanib a powerful treatment plan, and it is expected that Tivozanib can play a clinically significant role in the treatment of renal cell carcinoma.
References: [1] AVEO Oncology Announces US FDA Approval of FOTIVDA® (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma.
AVEO Oncology.
News release.
March 10, 2021.
Accessed March 10, 2021.
[2]Pal SK, Escudier B, Atkins MB, et al.
TIVO-3: Final OS analysis of a phase III, randomized, controlled, multicenter, open-label study to compare tivozanib to sorafenib in subjects with metastatic renal cell carcinoma ( RCC).
Presented at: 2020 ASCO Virtual Program; May 27, 2020.
Abstract 5062.
