European Medicines Agency recommends granting a conditional marketing authorisation for vismodegib
The authorisation concerns the treatment of adult patients with symptomatic metastatic basal cell carcinoma or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy
On 25 April 2013, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product vismodegib (Erivedge) 150 mg, hard capsule, intended for the treatment of adult patients with symptomatic metastatic basal cell carcinoma or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy.
The applicant for this medicinal product is Roche Registration Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
The active substance of Erivedge is vismodegib, an antineoplastic agent (ATC Code: L01XX43), an orally available small-molecule which acts by blocking specific genes involved in proliferation, survival, and differentiation of cells.
The benefits with vismodegib are its ability to reduce lesion size or sum of the longest diameter of lesions more than 30% or to provide complete resolution of ulceration in all target lesions in 48% of the patients with locally advanced basal cell carcinoma and in 33% of the patients with metastatic basal cell carcinoma.
The most common side effects are muscle spasms, alopecia, dysgeusia, weight decreased, fatigue and nausea. There is a high risk that vismodegib can cause embryo-foetal death or severe birth defects. A pregnancy prevention plan and a pharmacovigilance plan for vismodegib will be implemented as part of the marketing authorisation.
The approved indication is: “treatment of adult patients with symptomatic metastatic basal cell carcinoma, or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy". It is proposed that vismodegib be prescribed by physicians experienced in the treatment of advanced basal cell carcinoma.
Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for vismodegib and therefore recommends the granting of the marketing authorisation. The marketing authorisation is conditional.
A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage.