FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

PROPOSED AGENDA

 

May 3, 2004:

 

               8:00 a.m.               Call to Order                                                       ODAC  Chair        

                              Introduction of Committee                                  

 

                              Conflict of Interest Statement                Johanna Clifford, M.S., RN,

                                                                                                         Executive Secretary, ODAC

The committee will discuss New Drug Application (NDA) 21-649, Genasense™ (oblimersen sodium) Genta, Incorporated, proposed indication for use in combination with DTIC DOME ® (dacarbazine), Bayer Pharmaceuticals Corporation, proposed for the treatment of patients with advanced malignant melanoma.

 

               8:10 a.m.               Opening Remarks                              

 

               8:15 a.m.               Sponsor Presentation

 

               9:00 a.m.               FDA Presentation                                           

              

               10:00                     Break

               10:15 a.m.             Open Public Hearing                          

               10:45 a.m.             Committee Discussion

               12:00 p.m.             Lunch

 

The committee will discuss NDA 21-661, RSR 13 Injection (efaproxiral sodium) Allos Therapeutics Inc., proposed indication for use as an adjunct to whole brain radiation therapy in the treatment of brain metastases from primary breast cancer.

 

               12:45                     Sponsor Presentation                                                   

 

               1:30 p.m.               FDA  Presentation                                          

                                                                                                                                      

               2:45  p.m.              Open Public Hearing

               3:15 p.m.               Break

               3:30 p.m.               Committee Discussion

               5:00 p.m.               Adjourn

 

 

 

 

 

May 4, 2004:

 

               8:00 a.m.               Call to Order                                                       ODAC Chair         

                              Introduction of Committee                                  

 

                              Conflict of Interest Statement                Johanna Clifford, M.S., RN,

                                                                                                         Executive Secretary, ODAC

The committee will discuss safety concerns associated with Aranesp (darbepoetin alfa) Amgen, Inc., and Procrit (epoetin alfa) Ortho Biotech, L.P., both of which are indicated for the treatment of anemia associated with cancer chemotherapy.

 

               8:10 a.m.               Opening Remarks                                             

 

               8:15 a.m.               Sponsor Presentations

                                             .

               9:30a.m.                FDA Presentation                                           

                                                                                                          

               10:00 a.m.             Break

 

               10:15 a.m.             Open Public Hearing

 

               10:45 a.m.             Committee Discussion

 

               12:00 p.m.             Lunch

 

The Committee will discuss colo-rectal cancer endpoints as a follow up to the

 November 2003 FDA Workshop.

 

 

               12:45 p.m.             Introduction of Committee                                   ODAC Chair

 

                                             Conflict of Interest Statement                Johanna Clifford, M.S., RN, Executive Secretary, ODAC

 

               1:00 p.m.               FDA Presentation                                                             

 

               1:20 p.m.               Presentation                                                                     

 

               1:50 p.m.               Presentation         

                                                             

               2:30 p.m.               Open Public Hearing

 

               3:00 p.m.               Break

 

               3:15 p.m.               Committee Discussion

                                                                          

               5:00 p.m.               Adjourn