BRIDGEWATER, N.J., March 11 /PRNewswire/ -- The totality of scientific data submitted in recent months to the U.S. Food and Drug Administration (FDA) in preparation for the March 13th Oncologic Drugs Advisory Committee Meeting (ODAC) reaffirms that erythropoiesis-stimulating agents (ESAs) are safe and effective when used according to the product label to treat chemotherapy- induced anemia (CIA). ESAs are an important treatment option for CIA patients as the only proven therapeutic alternative to blood transfusions.
"ESA use within the label has not been associated with increased risk
of mortality or disease progression," said Craig Tendler, M.D., Vice
President, Medical Affairs, Oncology/Nephrology, Ortho Biotech Products,
L.P. "Ortho Biotech looks forward to Thursday's ODAC meeting, at which we
hope that responsible recommendations will be made based on the totality of
available evidence, including a substantial body of scientific data
submitted to the FDA over the past several months."
At the ODAC meeting, Ortho Biotech will:
-- Present the totality of data requested by the FDA at the May 2007 ODAC
meeting, including follow-up survival data submitted over the last four
months from studies accounting for approximately 50 percent of the
7,444 patients in the company's database;
-- Suggest that vascular thrombotic events (VTEs) are the most plausible
explanation for increased mortality with ESAs in cancer patients seen
in some studies with high hemoglobin targets;
-- Recommend additional research to address outstanding issues; and
-- Propose risk minimization strategies to reduce the risk of VTEs and
ensure safe and appropriate use.
The company has provided to the FDA all available clinical data from
relevant, randomized controlled trials of ESAs to treat CIA. "The known
risks of ESA use are prominently displayed in the current product labeling,
and we will
|SOURCE Ortho Biotech Products, L.P.|
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