- Label change based on data previously reported, communicated in late 2007
BRIDGEWATER, N.J., March 7 /PRNewswire/ -- Ortho Biotech Products, L.P. today modified prescribing information for PROCRIT(R) (Epoetin alfa), following guidance from the U.S. Food and Drug Administration (FDA) to revise labeling for all drugs within the erythropoiesis-stimulating agent (ESA) class.
Modifications to the label were based on an unplanned interim analysis of Amgen's PREPARE study in women with breast cancer receiving preoperative chemotherapy, and from GOG-191, a study of advanced cervical cancer patients conducted by the Gynecologic Oncology Group with support from Ortho Biotech. Both investigational studies were designed to evaluate the efficacy of maintaining hemoglobin levels greater than 12 grams per deciliter of blood (g/dL) and observed lower survival in patients being treated with ESAs. However, neither study showed a statistically significant effect on survival or tumor outcomes.
"These studies are consistent with results from previous studies demonstrating that ESAs should not be used to enhance the response to chemotherapy or radiotherapy, and should be administered to achieve a hemoglobin level of less than 12 g/dL," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/ Nephrology, Ortho Biotech Products, L.P. "We look forward to thoughtful consideration of the totality of available scientific evidence at next week's FDA Oncologic Drugs Advisory Committee Meeting (ODAC), including a substantial body of data that has been submitted to the agency over the past several months."
Ortho Biotech remains confident in the safety and efficacy of PROCRIT
when used at the lowest dose to avoid transfusion in anemic patients
receiving concomitant chemotherapy. The company also remains committed to
continuing to work with the FDA to ensure that physicians have the most
up-to-date information to s
|SOURCE Ortho Biotech Products, L.P.|
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