Food and Drug Administration

CENTER FOR DRUG EVALUATION AND RESEARCH    

Oncologic Drugs Advisory Committee

 

Meeting Agenda

 

July 27, 2004

 

8:30 a.m.                                  Call to Order and Opening Remarks          Otis Brawley, M.D.

                                    Introduction of Committee                                                          Guest Chair, ODAC

 

                       Conflict of Interest (COI) Statement                                Johanna Clifford, M.S.,RN

                                                                                                                            Executive Secretary, ODAC


 

The committee will discuss New Drug Application (NDA) 21-677, ALIMTA (pemetrexed) Eli Lilly & Company, proposed indication for single-agent treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy.

 

8:45 a.m.          Introduction                                                                   Richard Pazdur, M.D., Director

                                                                                                              Division of Oncology Drug Products 

                                                                                                               Center for Drug Evaluation & Research, FDA

9:00 a.m.          Sponsor Presentation

                      Introduction and Objectives of the Presentation               Paolo Paoletti, M.D.
                                                                                                      Eli Lilly and Company

                                                Background on Non-Small Cell Lung Cancer                                Frances Shepherd, M.D.

                                                Second Line                                                                  Princess Margaret Hospital

                                                                                                                                    University of Toronto                                                   

 

                                                Alimta Development                                    Roy Herbst, M.D., Ph.D.

                                                                                                                  M.D. Anderson Cancer Center

                                                                                                                                    University of Texas

                                               

                                                Clinical Efficacy from the Pivotal Study JMEI                                 Paul Bunn, M.D.

                                                                                                                                    University of Colorado Cancer Center

 

                                                Safety Profile from the Pivotal Study JMEI                           Richard Gralla, M.D.

                                                                                                                                    Multinational Association of Supportive

                                                                                                                  Care in Cancer

                                               

                                                Overall Conclusions                                    Paul Bunn, M.D.                                                      

                                                                                                             

10:00 a.m.              FDA Presentation                                                 

 

                        Clinical Review                                                             Martin H. Cohen, M.D., Medical Officer

                                                                                                            Division of Oncology Drug Products, FDA

 

                        Statistical Review                                                          Yong-Cheng Wang, Ph.D., Statistical Reviewer

                                                                                                            Division of Oncology Drug Products, FDA

                       

10:45 a.m.             Break

 

11:00 a.m.        Open Public Hearing  

 

12:00 p.m.        Questions from the Committee

 

12:30pm.               Lunch

 

 1:30 p.m.         ODAC Discussion

 

 4:00 p.m.         Estimated Time of Adjournment