Oncologic Drugs Advisory Committee: October 5, 2009

FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
Oncologic Drugs Advisory Committee
AGENDA
October 5, 2009
Page 1 of 2
8:00 a.m. Call to Order
Introduction of Committee Chair, ODAC
Conflict of Interest Statement Nicole Vesely, Pharm.D.
Designated Federal Official, ODAC
The committee will discuss supplemental biologics license application (sBLA) 103949/5153.0, PEGINTRON (peginterferon alfa-2b) injection, manufactured by Schering Corporation. The proposed indication (use) for this product is as an adjuvant (additional) treatment for melanoma, a kind of skin cancer. The primary treatment for melanoma that is metastatic (has spread) to the lymph nodes is surgery to remove both the original cancer and lymph nodes surrounding the cancer. PEGINTRON’s proposed use is as a treatment in addition to, or as an “adjuvant,” to surgery.

abrir aquí para acceder al documento FDA:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM182438.pdf