Aveo Oncology: The FDA Approved FOTIVDA for Adults with Relapsed or Refractory Advanced RCC

Aveo Oncology Received FDA Approval for FOTIVDA for Advanced RCC

Aveo Oncology (AVEO) drug FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) 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 plans to make FOTIVDA available to patients in the U.S. by March 31, 2021.
  • The approval of FOTIVDA 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 application is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects.
  • Patients enrolled in the TIVO-3 study were randomized 1:1 to receive either FOTIVDA or sorafenib. The main efficacy outcome measure was progression-free survival (PFS), assessed by a blinded independent radiology review committee. Other efficacy endpoints were overall survival (OS) and objective response rate (ORR).
  • Median PFS was 5.6 months in the FOTIVDA arm compared with 3.9 months for those treated with sorafenib.  
  • Median OS was 16.4 and 19.2 months, for the FOTIVDA and sorafenib arms, respectively.
  • ORR was 18% for the FOTIVDA arm and 8% for the sorafenib arm.
  • The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough and stomatitis.
  • The most common grade 3 or 4 laboratory abnormalities (≥5%) were decreased sodium, increased lipase, and decreased phosphate.

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