I have written several full length articles on the subject of my favorite monoclonal antibody, Humax-CD20. The technical name is ofatumumaband for reasons known only to themselves, the owners of this important drug (GlaxoSmithKline) have chosen the trade name of Arzerra. Who comes up with these names anyway? Sounds like a new car from South Korea, if you ask me. I bet we could have come up with a better name if anyone had thought to ask us chickens.
No rest for the weary
The FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting is scheduled for May 29 of this year at Orlando, Florida. They schedule a slot of time when interested members of the public may speak their minds, give the committee something to chew on. I keep my ear close to the ground on these things and my sense of it is that this is no slam dunk application just waiting for the FDA rubber stamp. I think we as a patient community have to do what we can to give this the good old push and shove and get it over the goal line. Otherwise we have no one to blame ourselves if things go south.
So, I will be packing my bags and heading out to Orlando, Florida. In keeping with our no strings attached policy, I will be paying my own fare, spending my own bucks to get to this meeting and speak on your behalf. Money makes the world go round but you have my word that no drug company will ever “buy” me with nice little junkets and freebies.
For now, what I need from you are your comments, your thoughts and ideas on why this is an important drug and why we want the FDA to approve it for use in CLL patients. I strongly urge you to use the “comments” section at the end of this article. That way everyone can read what others are saying, a terrific way of getting some brainstorming going. For those of you who are newcomers to the CLL scene, below are the links to the recent Humax-CD20 articles we published. Reading them again may be a good idea for the old timers as well, refresh your understanding of why this drug is important to us.
Does Humax-CD20 work? (latest)
A smarter monoclonal (background)
Down the road, I may ask you to do a bit of letter writing campaign to the FDA. I am convinced this is a drug we must have available to us. It works better than Rituxan, has fewer problems because it is fully humanized (as opposed to the mouse-juice of Rituxan) and in any case it is good to have a little competition going between the two drugs. Who knows, it might even bring the price down. Sigh. Heck, with a bit of luck our Canadian members might get hold of this drug before they finally get access to Rituxan!
What do you think? Speak up!