Regulatory Decision Summary for Metvix

Two pivotal studies support the use of Metvix in combination with daylight in patients with AK: Study 29112 involving 131 patients in Europe and Study 29102 involving 100 patients in Australia.

Each of these studies was a randomized study in the form of an intra-individual comparison between Metvix daylight photodynamic therapy (DL-PDT) on one side of the face/scalp and Metvix conventional photodynamic (c-PDT) on the contralateral side. The primary efficacy objective of the study was to show the non-inferiority of Metvix DL-PDT versus Metvix c-PDT after a single treatment, in patients with mild and/or moderate AK. The primary efficacy endpoint was the percentage change from baseline in the total number of treated mild lesions per side at Week 12. In study 29112, the mean reduction in the total lesions was 70.1% for the Metvix DL-PDT side and 73.6% for the Metvix c-PDT side; the 95% confidence interval (CI) of the mean between treatment differences was below the predefined non-inferiority (NI) limit of 15% with a 95% CI of (-9.5; 2.4). In study 29102, the mean reduction in mild lesions was 89.2% for the Metvix DL-PDT side versus 92.8% for the Metvix c-PDT side; the 95% CI of the mean between treatment differences was below the predefined NI limit of 20% with a 95% CI of (-6.8; -0.3). Except for pain (which is less using daylight therapy), the safety profile of Metvix DL-PDT was similar to that of Metvix c-PDT in each of the two studies.

There are sufficient data to support the efficacy and safety for Metvix daylight-PDT and for a single treatment regimen of Metvix c-PDT in the treatment of mild to moderate AK lesions. The climate of Canada will allow for the necessary exposure period of 2 hours in appropriate daylight conditions. Light conditions will be appropriate light if the weather is suitable to stay comfortably outdoors for 2 hours; if the weather is rainy or likely to become so, Metvix daylight treatment should not be used. In conclusion, The benefits are considered to outweigh the risks for the proposed Metvix daylight indication.