Aveo Pharma's Stock Trading Higher On Much Awaited FDA Approval For Tivozanib In Relapsed Kidney Cancer

The FDA has finally approved AVEO Pharmaceuticals Inc’s (NASDAQ: AVEO) tivozanib for advanced renal cell carcinoma, nine years after it first submitted its marketing application to the agency.

  • The label covers relapsed or refractory renal cell carcinoma who have received two or more prior systemic therapies.
  • Tivozanib, a tyrosine kinase inhibitor, witnessed rejection and a bumpy road toward refiling. The drug will now be marketed as Fotivda.
  • The approval has set off a scramble to make the most out of the drug before its U.S. patent expires in 2022. The company said it’s applying for a patent term extension to stretch it out to 2027. See the latest 10K here.

Tivozanib regulatory pathway timeline:

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Posted In: BiotechNewsHealth CareSmall CapFDAGeneralKidney Cancerrenal cell carcinoma
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