logo
  

FDA Approves AVEO Oncology's Fotivda For Renal Cell Carcinoma

Shares of AVEO Oncology (AVEO) jumped about 20% in extended trading hours Wednesday after the company announced that the FDA approved Fotivda (tivozanib) for the treatment of patients with relapsed or refractory advanced renal cell carcinoma.

Fotivda is the first therapy approved for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. The company plans to make the treatment available to patients in the U.S. by March 31, 2021.

Fotivda is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

The approval of Fotivda 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 application is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects.

AVEO closed Wednesday's trading at $15.28, up $7.20 or 89.11%, on the Nasdaq. The stock further gained $3.08 or 20.16% in the after-hours trade.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Viona Pharmaceuticals Inc. has recalled type 2 diabetes drug Metformin in the form of oral film-coated tablets for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement. Ford Motor Co. on Monday issued a recall for a total of 19,626 2021 F-Series Super Duty vehicles with dual rear wheels in North America. These include 17,616 vehicles in the U.S. and federal territories; 1,779 in Canada; and 231 in Mexico. The affected vehicles are equipped with front-wheel hub extenders... Royal Philips has recalled specific sleep and respiratory care devices due to the potential health risks related to the polyester-based polyurethane or PE-PUR sound abatement foam component. The affected products include Bi-Level Positive Airway Pressure or Bi-Level PAP, Continuous Positive Airway Pressure or CPAP, and mechanical ventilator devices.
RELATED NEWS
Follow RTT