Approval sought for Rituximab in CLL - Why?

Doesn't this sound like the biggest non-news of the month? Rituxan is used routinely to treat CLL, both in combination and alone, though the latter is less frequent.

The following article is important for two reasons. First, it lets the companies advertise rituximab for use in CLL. There are competitors coming, namely Arzerra (HuMax-CD20), which should be approved for CLL this year, as well as several other CD20 drugs.

Secondly, with Obamacare looming, it is likely that off-label drug usage will be curtailed if not eliminated totally. With CLL such an important revenue source for the drug companies, it would behoove the company to have as many applications as possible for the drug already in place.


Here's the press release:

Genentech And Biogen Idec Submit Applications To The FDA For Rituxan For Most Common
Article Date: 22 May 2009 - 4:00 PDT


Genentech, Inc. and Biogen Idec (Nasdaq:BIIB) announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan® (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL). The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months.

The applications are based on positive results from two of the largest global Phase III clinical trials conducted in patients with CLL. The randomized, comparative studies, known as CLL8 and REACH, showed that Rituxan plus standard chemotherapy for CLL extended the time patients lived without the cancer advancing (progression-free survival or PFS) compared to those receiving chemotherapy alone. In CLL8, previously untreated patients who received Rituxan plus chemotherapy had a 69 percent improvement in PFS (41 percent risk reduction, hazard ratio=0.59; p<0.0001; 95% confidence interval: 0.44,0.72) compared to those who received chemotherapy alone.