Advice
Following a resubmission:
5 aminolaevulinic acid (as hydrochloride) (Ameluz®) is accepted for use within NHS Scotland.
Indication under review: Treatment of superficial and / or nodular basal cell carcinoma (BCC) unsuitable for surgical treatment due to possible treatment-related morbidity and / or poor cosmetic outcome in adults.
In a phase III study of patients with BCC, up to two cycles of photodynamic therapy (PDT) with 5 aminolaevulinic acid gel was non-inferior to PDT with an alternative photosensitising agent for the primary endpoint, complete clearance, defined as clearance of all treated lesions, assessed visually at 12 weeks after the last PDT.
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Medicine details
- Medicine name:
- 5-aminolaevulinic acid (Ameluz)
- SMC ID:
- 1260/17
- Indication:
- Treatment of superficial and / or nodular basal cell carcinoma (BCC) unsuitable for surgical treatment due to possible treatment-related morbidity and / or poor cosmetic outcome in adults.
- Pharmaceutical company
- Biofrontera Bioscience GmbH
- BNF chapter
- Skin
- Submission type
- Resubmission
- Status
- Accepted
- Date advice published
- 12 February 2018