Comments on: Why Humax-CD20 must be approved

By: Chaya Venkat

Chaya Venkat — Wed, 01 Jul 2009 03:52:13 +0000

pvplunk1:

Don’t give up just yet!

We will wait until October 1, 2009. Hopefully Arzerra will be approved. If not, that is when we get proactive with our letter writing campaign and see if we can change the ballgame. We won’t know how much influence we have until we try. Right?

By: pvplunk1

pvplunk1 — Wed, 01 Jul 2009 03:38:23 +0000

The news and the FDA’s inactions/delays on Arzerra is very disappointing for me. I failed FCR on first try, probably refractory already, approaching SCT and need the Arzerra option for some sort of remission prior to transplant. As far as I’m concerned, the FDA process is total useless. It’s a wonder we have any approved drugs.

By: Chaya Venkat

Chaya Venkat — Tue, 16 Jun 2009 16:31:03 +0000

Never a dull day. I just saw the press release from GSK and Genmab that the FDA has delayed final approval of Humax-CD20 (Arzerra, ofatumumab) by another 3 months. Previously it was thought we would have a decision no later than August 1. Here is quote from the companies, the new decision date is October 31.

GlaxoSmithKline (NYSE: GSK) and Genmab A/S (OMX: GEN) today announced that the United States Food and Drug Administration (FDA) informed the companies that the agency has extended the action date for the ofatumumab BLA application by three months.
The BLA was submitted on January 30, 2009 and was granted priority review by the FDA. Under priority review, the FDA sets the target date for a decision at six months, rather than the standard 10 month review. The three month extension will allow the agency to review additional chemistry and manufacturing data submitted on June 5. The new action date for the BLA is October 31, 2009.”

By: Myrna

Myrna — Tue, 16 Jun 2009 14:24:02 +0000

Thank you I’am on campath right now and praying for a new breakthrough.

By: dentymic

dentymic — Wed, 03 Jun 2009 14:28:06 +0000

Dentymic;
As who had a severe allergic reaction to initial treatment with Rituximab (Vasculitius) I applaud your efforts to get this drug approved.I’m just starting Fludarabine and Cytoxin mix therapy (without any Rituxin). In between I’ve been trated twice with chlorambucil.
I’m ready to write letters , e-mails etc. if need be.
Thanks for all you continue to do for those with CLL.

By: Harley

Harley — Mon, 01 Jun 2009 13:24:33 +0000

Here’s a link to the article’s web page:
http://www.startribune.com/lifestyle/health/46554437.html

Harley

By: Jim

Jim — Sun, 31 May 2009 22:42:27 +0000

Correction–the article in the Minneapolis paper is Sunday, May 31, not June 1.