January 2, 2014 / 12:35 PM / 4 years ago

FDA lifts hold on studies testing Cell Therapeutics' cancer drug

(Reuters) - Cell Therapeutics Inc said the U.S. Food and Drug Administration lifted a hold imposed in June last year on studies testing the company’s blood cancer drug.

The company’s shares rose about 3 percent to $1.97 in premarket trading on Thursday.

Cell Therapeutics said it received the notification from the regulator on December 26.

The FDA placed the hold after a patient treated with a combination of the drug, tosedostat, and a chemotherapy drug died of a heart muscle infection.

Under the hold, the company could not enroll new patients in any trials of tosedostat.

The regulator asked for more information on all heart-related events in patients treated with the drug.

Tosedostat is being tested in mid-stage trials in the United States and European Union on elderly patients with two forms of blood cancer - acute myeloid leukemia and myelodysplastic syndrome.

Reporting by Vrinda Manocha in Bangalore; Editing by Kirti Pandey

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below