July 20, 2009 / 1:03 PM / 11 years ago

UPDATE 1-FDA accepts Spectrum's response on cancer drug

* FDA accepts resubmission as Class 1 response

* FDA sets Sept. 7 as decision date

* Spectrum shares up 12 pct in premarket trade

July 20 (Reuters) - Spectrum Pharmaceuticals Inc (SPPI.O) said U.S. health regulators accepted for review the company’s response on its experimental cancer drug, Zevalin, as a Class 1 submission — which typically means the regulators would review the drug within 60 days.

The U.S. Food and Drug Administration set Sept. 7 as its decision date on the drug the company said.

In July, the FDA had asked for more data on Spectrum’s application for the approval of an additional use of Zevalin to treat non-Hodgkin’s lymphoma (NHL). [ID:nBNG174679]

Zevalin is already approved as a treatment for patients with relapsed or refractory, low-grade or follicular B-cell NHL.

Shares of the company were up 12 percent at $6.20 in premarket trade. They closed at $5.55 Friday on Nasdaq.

For the alerts, please double-click [ID:nWNAB8708] (Reporting by Shailesh Kuber in Bangalore; Editing by Aradhana Aravindan)

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