AVEO Oncology (AVEO) Announces Addition of FOTIVDA into National Comprehensive Cancer Network Clinical Practice Guidelines

March 29, 2021 7:05 AM EDT
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AVEO Oncology (Nasdaq: AVEO) today announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include FOTIVDA® (tivozanib) as a recommended regimen for subsequent therapy. The subsequent therapy category follows the first-line treatment regimen recommendations for patients with clear cell histology renal cell carcinoma (ccRCC). 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).

“FOTIVDA’s addition to the NCCN Guidelines provides further validation for its potential to serve as an important evidence-based, well tolerated treatment option for patients with relapsed or refractory advanced RCC,” said Michael Bailey, president and chief executive officer of AVEO. “As previously announced, launch efforts are now underway, and we are committed to bringing this promising therapy to as many appropriate patients as possible.”

The NCCN Clinical Practice Guidelines are the recognized standard for clinical policy in cancer care and are developed through review of evidence and recommendations from physicians and oncology researchers. The current NCCN RCC guidelines categorically make treatment recommendations for first-line or subsequent therapy options for RCC patients. FOTIVDA is now recommended by the NCCN Guidelines as a subsequent therapy for patients with ccRCC who have received two or more prior systemic therapies (Category 2a). FOTIVDA’s addition to the NCCN Guidelines follows its recent U.S. FDA approval, which was 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 approval was also supported by three additional trials in RCC and included safety data from over 1,000 clinical trial subjects.

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