AMELUZ (5-aminolevulinic acid) - Basal cell carcinomas

The Committee deems that the clinical benefit of AMELUZ (5-aminolevulinic acid) 78 mg/g gel is substantial only in the treatment of superficial basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.

Considering:

• demonstration in a phase 3 clinical study in adults with non-aggressive superficial or nodular basal cell carcinoma (BCC) of the non-inferiority of 5-aminolevulinic acid compared to methyl aminolevulinate (METVIXIA) on complete clearance of all treated lesions assessed 12 weeks after the last photodynamic therapy (PDT; two sessions with an interval of one week between sessions, that may be repeated in the event of non-response or an inadequate response at week 12),
• recurrences with 5-aminolevulinic acid (2.9% and 6.7% of lesions, respectively, 6 and 12 months after the last PDT) comparable with methyl aminolevulinate (4.3% and 8.2% of lesions, respectively, 6 and 12 months after the last PDT),
• the similar safety profile to that of methyl aminolevulinate, primarily including local reactions, such as irritation, erythema and pain,

the Committee deems that AMELUZ (5-aminolevulinic acid) 78 mg/g gel provides no clinical added value (CAV V) compared to METVIXIA (methyl aminolevulinate) in the treatment of superficial basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.