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Home Industry News Roche receives CHMP backing for Erivedge approval

Roche receives CHMP backing for Erivedge approval

3rd May 2013

Roche has announced that the European Committee for Medicinal Products for Human Use (CHMP) has recommended the conditional approval of its new skin cancer drug Erivedge.

The European Medicines Agency committee has endorsed the therapy for use among adult patients with symptomatic metastatic basal cell carcinoma or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy.

Should the European Commission approve the drug, it would become the first licensed therapy for these rare and fatal forms of skin cancer, which are collectively classed under the term advanced basal cell carcinoma.

The CHMP ruled that Erivedge offers a favourable benefit-to-risk balance, based on the quality, safety and efficacy data submitted by Roche.

Dr Hal Barron, Roche's chief medical officer and head of global product development at Roche, said: "Erivedge was shown to substantially shrink tumours in a significant proportion of patients in clinical trials and we hope this medicine will soon be available to patients in Europe."

This comes after the company was granted European approval for the personalised breast cancer drug Perjeta in March 2013.ADNFCR-8000103-ID-801581043-ADNFCR

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