PIONEER Trial Interim Data to Provide Basis for Review Supported by Gender-Specific STELLAR Trial Results
SEATTLE, June 1 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)
(Nasdaq: CTIC; MTAX) announced that at a recent meeting with the U.S. Food and
Drug Administration (FDA), CTI and the FDA agreed on a new drug application
(NDA) route for XYOTAX(TM) (paclitaxel poliglumex) for women with lung cancer.
The FDA agreed to review an NDA submission based on interim results of the
PIONEER trial with the results of the STELLAR 3 and 4 trials to support the
filing. Based on this feedback, if the PIONEER trial meets its pre-specified
interim endpoint, CTI plans to submit an NDA in the first half of 2007 and
would request a priority (six month) review based on the fast track
designation, instead of the standard (ten month) review as previously planned.
"We are happy with the outcome from our pre-NDA meeting with the FDA,
which focused on how best to utilize the survival data observed among women in
the STELLAR 3 and 4 trials and confirmatory data from our ongoing gender-
specific PIONEER trial," stated James A. Bianco, M.D., President and CEO of
CTI.
"By reviewing an NDA based on interim data from the PIONEER study, this
approach could reduce the approval process for this novel therapeutic by more
than 12 months over a filing based on full results of the PIONEER study."
"Lung cancer is a major unmet medical crisis for women and will kill
70,000 women this year. The biology of lung cancer is different in women and
they appear to respond differently to treatment than men. We need to examine
the potential for gender-specific therapy, not only in lung cancer but in a
number of cancers that are known to express the estrogen receptor. Increasing
knowledge of human biology is the ultimate promise of personalized medicine,"
Bianco added.
[snip] |
