AVEO Oncology (AVEO) Announces U.S. Commercial Availability of FOTIVDA for Treatment of Adult Patients With R/R Advanced RCC Ahead of Previous Guidance

March 22, 2021 7:03 AM EDT
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AVEO Oncology (Nasdaq: AVEO) today announced that FOTIVDA® (tivozanib) is now commercially available in the United States (U.S.) ahead of the previous March 31, 2021 guidance. On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved FOTIVDA for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

“We are thrilled to begin bringing FOTIVDA to patients battling relapsed or refractory kidney cancer,” said Michael Bailey, president and chief executive officer of AVEO. “With its differentiated tolerability and efficacy profile, FOTIVDA has the potential to serve as a meaningful, evidence-based treatment option for the population of patients who have previously received two prior lines of systemic therapy.”

“We are keenly focused on ensuring that FOTIVDA is available to as many appropriate patients as possible,” said Mike Ferraresso, chief commercial officer of AVEO. “As part of this effort and our commitment to the RCC community, we have put in place an assistance program, AVEO ACE, which we believe will optimize patient access and help patients navigate their treatment journey. With the early FDA approval, the team has worked hard to make FOTIVDA available to patients as quickly as possible through our distribution partners and we believe we are well positioned for the successful launch of FOTIVDA.”

The AVEO ACE Patient Support program is designed to offer a comprehensive suite of services dedicated to providing access and personalized support to patients and their loved ones throughout the FOTIVDA treatment journey. Regardless of a patient’s insurance or financial circumstances, AVEO ACE is available to connect them to resources they may need, with the goal of making access to FOTIVDA simple and streamlined. The program is committed to helping identify payor-specific prior authorizations and appeals to address patient needs, offering programs for insurance related delays, and connecting patients, regardless of insurance type, to resources that can address common access and reimbursement challenges. For more information, please call AVEO ACE at 1-833-FOTIVDA (1-833-368-4832) Monday-Friday from 8:00 AM to 8:00 PM Eastern Time.

FOTIVDA is available through a limited distribution network comprised of specialty pharmacies (Biologics & Onco360) and specialty distributors: Amerisource Specialty Distribution, Oncology Supply, McKesson Plasma and Biologics, McKesson Specialty and Cardinal Specialty.

About FOTIVDA® (tivozanib)

FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models1. FOTIVDA was discovered by Kyowa Kirin.

INDICATIONS

FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.



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