Specrtum Pharmaceuticals (Nasdaq: SPPI) are 20% as of 7:45 a.m. Eastern on about 3,000 shares traded. The FDA asked for data from the company’s already completed Phase III study to support the company’s proposed labeling of its product Zevalin as a first-line consolidation therapy for treating non-Hodgkins lymphoma.
No additional clinical studies have been requested. The additional data requested do not involve new data analyses.
Still, the request appears to be a hiccup for shareholders who may have been expecting a fairly straightforward process for getting a supplemental biologics license application this month for Zevalin from the FDA in treating one of the five most common cancers in the U.S. Timing for approval was generally expected shortly after the FDA set a target date of July 2, 2009 for its review.