DDMAC: BIOGEN IDEC'S ZEVALIN BROCHURE MISLEADING
The FDA has cited Biogen Idec for disseminating a promotional brochure that fails to present important risk information about its cancer drug Zevalin.
The company's Results 2004 Coding Update brochure is false or misleading because it makes claims about who may benefit from the Zavalin (ibritumomab tiuxetan), but omits risk information and material facts regarding the indication for the drug, according to the Dec. 15, 2005, warning letter recently posted by the agency's Division of Drug Marketing, Advertising and Communications (DDMAC).
Biogen Idec disseminated the brochure at the American Society of Health-Systems Pharmacists Summer Meeting in June 2005. The brochure raises significant public health and safety concerns about Zevalin because it suggests the drug is safer and more effective than has been demonstrated by substantial evidence or clinical experience, DDMAC said. Zevalin is a cancer drug for patients with non-Hodgkin's lymphoma.
While the brochure presents some risk information from the Boxed Warning and Warnings sections of the approved product labeling (PI) on the second page, it "omits most of the risk information from the Boxed Warning, Warnings, Precautions and Adverse Reactions sections of the PI for the Zevalin therapeutic regimen," DDMAC states.
To view a copy of the letter, go to http://www.fda.gov/cder/warn/2005/Zevalin-letter.pdf (http://www.fda.gov/cder/warn/2005/Zevalin-letter.pdf).