* FDA staff raise issues with safety, effectiveness
* Wednesday panel meeting postponed due to weather
* Company says drug works, side effects manageable
* Shares fall nearly 40 pct
(Updates panel meeting postponed)
By Lisa Richwine
WASHINGTON, Feb 8 U.S. drug reviewers
questioned effectiveness data from Cell Therapeutics Inc
(CTIC.O) (CTIC.MI) for an experimental lymphoma drug and said
the medicine had substantial side effects, according to
documents released on Monday.
Cell Therapeutics shares fell 42 cents to close at 64 cents
A Food and Drug Administration advisory panel review of the
drug, originally scheduled for Wednesday, was postponed due to
weather. The Washington region is digging out from a storm that
dumped two feet (half-meter) of snow, and more snow was
forecast for Tuesday and Wednesday.
Seattle-based Cell Therapeutics is seeking approval to sell
pixantrone under the brand name Pixuvri for treating
non-Hodgkin's lymphoma that has stopped responding to other
FDA reviewers, in an analysis prepared for the advisory
committee, said issues raised in their review included "the
reliability of (the efficacy) conclusions" and "substantial
hematologic and cardiac toxicity."
The company's main study tested 140 patients whose cancer
worsened after at least two chemotherapy regimens, FDA staff
said. That was less than half the 320 originally planned. Cell
Therapeutics told the FDA it had trouble attracting patients
because doctors preferred multiple chemotherapy drugs or
supportive care, the FDA staff summary said.
FDA reviewers also said they had concerns about re-readings
of patient results by independent experts.
The agency said it would ask the advisory panel if the
company has provided enough evidence that pixantrone worked and
if benefits outweighed risks.
The FDA usually follows panel recommendations when deciding
whether to approve drugs. A final decision is due by April 23.
Cell Therapeutics spokesman Dan Eramian said many of the
key issues raised by FDA staff were addressed in a company
summary prepared for the panel.
In the summary, the company said pixantrone worked better
than other drugs with "manageable toxicities." Twenty percent
of patients treated with pixantrone met the study's main goal
of having a major decrease in their disease, compared with
about 6 percent with a different medicine.
Non-hodgkin's lymphoma is a blood cancer that affects about
66,000 U.S. patients annually. Patients who have relapsed
following two prior regimens often live less than six months.
"Pixantrone fulfills an unmet medical need in multiply
relapsed patients with aggressive NHL," Cell Therapeutics
FDA reviewers said data suggested pixantrone could be toxic
to the heart, "but no conclusions can be drawn" about how the
risks compared with cancer drugs called anthracyclines or
anthracenediones, which are known to cause cardiac damage.
In the company study, deaths and serious complications from
heart damage and bone marrow suppression "were all more common"
in patients treated with pixantrone versus other cancer drugs,
FDA staff said.
Swiss drugmaker Novartis NOVN.VX has an option for a
worldwide license to develop and sell pixantrone.
The FDA has not set a new date for the panel meeting, FDA
spokeswoman Karen Riley said.
(Reporting by Lisa Richwine; Editing by Gerald E. McCormick;
Steve Orlofsky; and Carol Bishopric)