foodconsumer.org: FDA approves leukemia drug

FDA approves leukemia drug
================================================================================
admin on 02/22/2010 22:52:00
 
Rituximab
On February 18, 2010, the U.S. Food and Drug Administration granted approval to
rituximab (Rituxan, Genentech), in combination with fludarabine and
cyclophosphamide (FC), for the treatment of previously untreated and previously
treated patients with chronic lymphocytic leukemia (CLL).  The approval was
based on a clinically meaningful and statistically significant increase in
progression-free survival (PFS) observed in two randomized multicenter
open-label trials in patients randomized to receive either FC or the combination
of FC with rituximab (R-FC).
In both studies patients received intravenous (i.v.) fludarabine 25 mg/m2/day
and cyclophosphamide 250 mg/m2/day, daily for 3 days, repeated every 28 days for
a total of 6 cycles.  Rituximab 375 mg/m2 by i.v. infusion was administered on
day 1 of the first cycle (the day before chemotherapy) and 500 mg/m2 i.v. on day
1 of subsequent cycles (on the same day as chemotherapy).  The primary efficacy
outcome was PFS, defined as the time from randomization to either disease
progression, relapse, or death.  Secondary endpoints included overall survival
(OS) and overall response rates determined by the 1996 National Cancer
Institute-sponsored Working Group Guidelines.
Study ML17102, also known as CLL8, was conducted by the German CLL Study Group
and enrolled treatment-naïve patients.  A total of 408 patients were randomized
to the R-FC arm and 409 patients to the FC arm.  The median age was 61 years
(30% were ≥ 65 years old), 74% were male, 31% were Binet stage C, 45% had B
symptoms, and more than 99% had ECOG performance status (PS) 0-1.
The primary efficacy endpoint was PFS as determined by the investigators.   The
median PFS were 39.8 months and 31.5 months in the R-FC and FC arms,
respectively [HR 0.56 (95% CI: 0.43, 0.71), p