FDA warns Amgen over cancer drug promotional video (updated)

Amgen

Yesterday 09:53

Adds company statement
Oct 27 (Reuters) - The US FDA has warned Amgen AMGN.O that a promotional video for its colorectal cancer drug was misleading because it highlighted the benefits while failing to adequately disclose serious safety risks and patient limitations, according to an update posted on the agency's website on Tuesday.
 
Here are some details:
In a warning letter dated August 12, the FDA said the video promoted the drug Vectibix as an option for adults with a type of advanced colorectal cancer and noted that infusions can take 60 minutes or less and do not require premedication
The regulator said that the video contained no information on risk, despite Vectibix carrying a boxed warning for severe skin reactions
The drug can also cause potentially fatal infusion reactions, lung disease, kidney failure and other serious side effects, the FDA said
The regulator said the video failed to disclose which type of patients can use Vectibix, including limits tied to tumor testing
"By failing to adequately communicate the full indication for Vectibix and limitations of use associated with Vectibix, the video creates a misleading impression about the drug's FDA-approved indication and use," the FDA said
The regulator told Amgen to stop using misleading promotional material, submit a written response within 15 working days and propose corrective communications for the video's audience
"An incorrect video file for a Vectibix advertisement was inadvertently submitted to FDA that did not contain the required risk information, but the file was never publicly disseminated," a company spokesperson said  
Amgen spokesperson further added the Vectibix advertisement that was publicly disseminated included the appropriate important safety information, and the company has submitted the correct file to the FDA.  

 (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shailesh Kuber and Vijay Kishore)
 ((Padmanabhan.Ananthan@thomsonreuters.com;))