viernes, 12 de mayo de 2017

Update of Upcoming Advisory Committee Meetings and Recently Posted Materials

May 25, 2017: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement


The committee will discuss biologics license application (BLA) 125545, for a proposed biosimilar to Amgen Inc.ʼs Epogen/Procrit (epoetin alfa), submitted by Hospira Inc., a Pfizer company. The proposed indications/uses for this product are: (1) For the treatment of anemia due to chronic kidney disease, including patients on dialysis and not on dialysis, to decrease the need for red blood cell (RBC) transfusion; (2) for the treatment of anemia due to zidovudine administered at ≤ 4,200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤ 500 m units/mL; (3) for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppresive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy; and (4) to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to <13 and="" are="" at="" blood="" dl="" elective="" for="" from="" g="" high="" loss="" noncardiac="" nonvascular="" p="" perioperative="" risk="" surgery.="" who="">

Contact Information

Lauren D. Tesh, PharmD, BCPS
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.

Webcast Information

CDER plans to provide a free of charge, live webcast of the May 25, 2017 meeting of the Oncologic Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2017 Meeting Materials, Oncologic Drugs Advisory Committee
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
Further information regarding this meeting can be found by clicking the link below.

No hay comentarios: