Food and Drug Administration

Center for Drug Evaluation and Research

Dermatologic and Ophthalmic Drugs Advisory Committee

Holiday Inn, The Ballrooms, Montgomery Village Avenue, Gaithersburg, Maryland

September 10, 2003

DRAFT Agenda


NDA 21-576, Methyl aminolevulinate hydrochloride, (Methyl aminolevulinate cream, 168mg/g) by PhotoCure ASA


8:30                 Call to Order and Opening Remarks                                        Robert S. Stern, M.D.


                         Conflict of Interest Statement                                                             Kimberly L. Topper, M.S.


8:45                 Introduction                                                                                  Jonathan Wilkin, M.D.


9:00                 Industry Presentation


Introduction                                                                            Kjetil Hestdal, M.D., Ph.D.,
Regulatory Overview                                                                           William Clementi, Pharm.D., F.C.P.
Photodynamic therapy with methyl aminolevulinate (MAL PDT). 

  Non-surgical Treatment of BCC                                                      Kjetil Hestdal, M.D., Ph.D.
Overview of Clinical Development

      Program of MAL PDT in BCC                                                      Kjetil Hestdal, M.D., Ph.D.
Efficacy in BCC: Placebo controlled studies                                   David M. Pariser, M.D., FACP
Efficacy in BCC: Active controlled studies,

                            including long term follow-up                                                           David M. Pariser, M.D.
Efficacy in High–Risk BCC,

including long term follow-up                                                        Prof Dédée F Murrell MA ,BMBCh , FAAD
Safety, including skin sensitization                                                    John Posner, Ph.D., FRCP
MAL PDT in BCC Benefit/risk                                                           Kjetil Hestdal, M.D., Ph.D.


10:00               Committee Discussion                                                                      


10:30               Break  


10:45               FDA Presentation -                                                                             Markham Luke, M.D., Ph.D.

                            Methyl aminolevulinate Cream (MAL)                                           Brenda Vaughan, M.D.

                            with Curettage and Photodynamic Therapy (PDT)                      Mohamed Al Osh, M.D.

                            for Nodular  Basal Cell Carcinoma (BCC)                         


11:45               Committee Discussion


12:15               Lunch


1:15                 Open Public Hearing


2:15                 Committee Discussion


3:15                 Break


3:30                 Questions


5:30                 Adjournment