Onco360 Selected as Partner for FOTIVDA
FOTIVDA® (tivozanib) Now Approved for the Treatment of Relapsed/Refractory Advanced Renal Cell Carcinoma Following Two or More Prior Systemic Therapies; Onco360® Selected as Specialty Pharmacy Partner
March 12, 2021, 09:00 AM Eastern Standard Time
Onco360 has been selected by AVEO Oncology to be a specialty pharmacy partner for FOTIVDA® (tivozanib), a new oral treatment for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
“The recent approval of FOTIVDA unlocks a new therapy option for treatment-experienced patients with previously treated advanced RCC who have limited treatment options. As a provider of this key treatment, Onco360 can support the highly specialized needs of RCC patients and their physicians across the US.”
“Onco360 is excited to be selected as a specialty pharmacy provider for FOTIVDA patients,” said Benito Fernandez, Chief Commercial Officer, Onco360. “The recent approval of FOTIVDA unlocks a new therapy option for treatment-experienced patients with previously treated advanced RCC who have limited treatment options. As a provider of this key treatment, Onco360 can support the highly specialized needs of RCC patients and their physicians across the US.”
Renal cell carcinoma (RCC) is the most common type of kidney cancer1, which is among the 10 most common cancers in both men and women.2 According to the American Cancer Society 2020 statistics, approximately 73,750 new cases of kidney cancer will be diagnosed and about 14,830 people will die from this disease.2 Local therapies are often used to treat RCC in earlier stages; however, RCC patients are typically asymptomatic until disease progression and require systemic and targeted treatments at diagnosis.3 Targeted drugs used to treat advanced kidney cancer or metastatic RCC work by blocking angiogenesis and/or important proteins in cancer cells that help them grow and survive.4 Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC but are associated with adverse events and side effects that commonly result in high rates of dose interruptions and reductions.5 A more potent, highly selective inhibitor of VEGF receptors may improve efficacy and tolerability, and thus meet an unmet need for efficacious agents with differentiated safety profiles for RCC patients.6
FOTIVDA is manufactured by AVEO Oncology, an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. The FDA’s approval of FOTIVDA, for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies, is based on AVEO’s pivotal Phase 3 study, TIVO-3, comparing FOTIVDA to sorafenib in relapsed or refractory advanced RCC following two or more prior systemic therapies. The study met its primary endpoint of progression-free survival (PFS), demonstrating a reduction in the risk of progression or death on treatment by 27% and a 44% improvement in median PFS compared to sorafenib (PFS hazard ratio of 0.73, p=0.02). Median PFS was 5.6 months for FOTIVDA compared to 3.9 months for sorafenib. The application is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects. For full prescribing information, visit FOTIVDA.com
American Cancer Society: What Is Kidney Cancer 2021. Available at https://www.cancer.org/cancer/kidney-cancer/about/what-is-kidney-cancer.html. Accessed January 2021.
2) American Cancer Society: Key Statistics About Kidney Cancer 2021. Available at: https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html. Accessed January 2021.
3) American Cancer Society: Kidney Cancer Treatment 2021. Available at: https://www.cancer.org/cancer/kidney-cancer/treating.html. Accessed January 2021.
4) American Cancer Society: Targeted Therapy for Kidney Cancer 2021. Available at: https://www.cancer.org/cancer/kidney-cancer/treating/targeted-therapy.html. Accessed January 2021.
5) Rini BI, Pal SK, Escudier BJ, et al. Lancet Oncol 2020; 21:95-104.
6) Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-3799.