Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Erivedge 150 mg, hard capsule, intended for the treatment of adult patients with symptomatic metastatic basal cell carcinoma or locally advanced basal cell carcinoma ( BCC ) inappropriate for surgery or radiotherapy.
The active substance of Erivedge is Vismodegib, an antineoplastic agent, an orally available small-molecule which acts by blocking specific genes involved in proliferation, survival, and differentiation of cells.
The benefits with Erivedge 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 Erivedge can cause embryo-foetal death or severe birth defects.
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 Erivedge be prescribed by physicians experienced in the treatment of advanced basal cell carcinoma.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Erivedge 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. ( Xagena )
Source: European Medicines Agency, 2013
XagenaMedicine_2013
