Cell Therapeutics, Inc.
(CTI) (Nasdaq and MTA: CTIC) announced that the Company has scheduled
a meeting with the U.S. Food and Drug Administration (FDA) in September to
discuss the possibility of filing a supplemental Biologics License
Application (sBLA) for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as
consolidation therapy after remission induction in previously untreated
patients with follicular non-Hodgkin's lymphoma. The basis for the filing
would be data from the First-line Indolent Trial that CTI recently gained
access to through an agreement with Bayer Schering Pharma.
"We are pleased to have scheduled a meeting with the FDA to discuss a
label expansion for Zevalin which could broaden its availability to
patients," said James A. Bianco, M.D., President and CEO of Cell
Therapeutics. "We continue to make progress with Zevalin on multiple fronts
with clarity on reimbursement rates, deployment of our national sales team
and now the opportunity to meet with the FDA to discuss possibly expanding
the label for Zevalin."
About the Phase III First-line Indolent (FIT) Trial
The multinational, randomized phase III First-line Indolent Trial (FIT)
evaluated the benefit and safety of a single infusion of Zevalin in
patients with CD20-positive follicular non-Hodgkin's lymphoma who had
achieved a partial response or a complete response after receiving standard
first-line chemotherapy regimens. The FIT trial results were presented in
one oral and two poster presentations at the American Society of Hematology
(ASH) conference in December 2007. The FIT trial demonstrated that when
used as a first-line consolidation therapy for patients with follicular
non-Hodgkin's lymphoma, Zevalin significantly improved the median
progression-free survival time from 13.5 months (control arm) to 37 months
(p