European regulators have recommended the approval of AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO)‘s drug for cancer treatment. The announcement is a big victory for the U.S. biotech that has faced a number of setbacks in bringing the drug to the market.
Following the announcement on Monday, Aveo’s shares surged 58% to $1.15 in premarket trading.
The European Medicines Agency (EMA) said experts at its Committee for Medicinal Products for Human Use (CHMP) had supported the once-daily drug for marketing approval as a first-line treatment for advanced renal cell carcinoma, or kidney cancer. The drug was also approved for treating adult patients with advanced kidney cancer who met certain criteria and had received one prior treatment with cytokine therapy.
The European Commission all recommendation for marketing made by the Committee for Medicinal Products for Human Use (CHMP) after a couple of months. Europe accounts for the highest incidence rates of kidney cancer in the world, with about 115,000 people diagnosed with cancers of the kidney, renal pelvis and the ureter in 2012. The marketing approval from the EMA comes after a series of stumbles for Aveo’s drug, tivozanib, or Fotivda.
The treatment which was first licensed by Aveo from Japan’s Kyowa Hakko Kirin more than seven years ago was turned down by the U.S. Food and Drug Administration (FDA) in 2013 for inconsistent study results. The company has since ended an agreement with Astellas Pharma Inc to help develop the drug.
Aveo paid $4 million last year to settle allegations that it misled investors about U.S. regulators’ concerns over its drug.
To seek FDA approval for Fotivda as a first- and third-line treatment for kidney cancer, Aveo will test the drug in a trial pitting the treatment against Bayer and Amgen’s approved drug for kidney cancer, Nexavar, or sorafenib. Results from the trial are expected in the first quarter of 2018.
Aveo granted specialty pharmaceutical business EUSA Pharma the European rights to tivozanib for the treatment of kidney cancer.
AVEO Pharmaceuticals is a biopharmaceutical company that specializes in delivering insights into cancer and related disease. The company’s primary products include AV-380, AV-203, Ficlatuzumab and Tivozanib.
