Food and Drug Administration
Center for Drug Evaluation and Research
Dermatologic and Ophthalmic Drugs Advisory Committee
Holiday Inn, The Ballrooms,
NDA 21-576, Methyl aminolevulinate hydrochloride, (Methyl aminolevulinate cream, 168mg/g) by PhotoCure ASA
Call to Order and Opening Remarks Robert S. Stern, M.D.
Conflict of Interest Statement Kimberly L. Topper, M.S.
Introduction Jonathan Wilkin, M.D.
Introduction Kjetil Hestdal, M.D., Ph.D.,
Regulatory Overview William Clementi, Pharm.D., F.C.P.
Photodynamic therapy with methyl aminolevulinate (MAL PDT).
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
Safety, including skin sensitization John Posner, Ph.D., FRCP
MAL PDT in BCC Benefit/risk Kjetil Hestdal, 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)
Open Public Hearing