Food and Drug Administration


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