Oslo, Norway, 18 February 2003
Today PhotoCure announces the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Metvix® PDT (photodynamic therapy) for the treatment of nodular and superficial basal cell carcinoma (BCC, skin cancer). PhotoCure ASA recently obtained an approvable letter from the US FDA for actinic keratosis (AK), pre-malignant skin lesions.
The NDA comprises data from six pivotal clinical studies, in which Metvix® PDT was used to treat 340 patients with a total of 498 BCC lesions. Metvix® PDT was compared to surgery and cryotherapy, which are the current standard therapies for BCC. Both efficacy and cosmetic outcome were assessed at three months, one year and two years after treatment. These studies provide unequivocal and consistent results on the efficacy of Metvix® PDT.
Multiple lesions can be treated simultaneously with Metvix® PDT. Only three hours application time before illumination as well as the patient tolerance of treatment contributes to making treatment with Metvix® PDT convenient for both patients and health care providers.
Professor Vidar Hansson, CEO and President of PhotoCure, commented: "The filing of our NDA for Metvix® PDT treatment of BCC is an important event, since the US is one of the biggest markets in the world with about one million new cases of BCC every year."