The European Medicines Agency (EMA) has recommended EU marketing approval for both Roche’s Erivedge and Astellas’ Xtandi in oncology indications.
In its latest round-up of opinions, the EMA’s Committee for Medicinal Products for Human Use (CHMP) gave its backing to Erivedge (vismodegib) for the treatment of advanced basal cell carcinoma and to Xtandi (enzalutamide) for the treatment of prostate cancer.
Specifically, the Erivedge recommendation is for the drug’s use for the treatment of adult patients with symptomatic metastatic basal cell carcinoma or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy.
The condition is the most common type of skin cancer in Europe, the US and Australia, and involves abnormal, uncontrolled growths or lesions on the skin.
The CHMP’s decision is based on clinical trials that demonstrated the drug was able to reduce the size of lesions.
Dr Hal Barron, Roche’s chief medical officer and head of global product development, said the recommendation was “encouraging news for patients”.
He added: “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 [if approved by the European Commission].”
Erivedge is already available in the US, where it received an earlier than expected approval from the FDA in January 2012.
Xtandi recommended in prostate cancer
Astellas’ Xtandi was recommended for use in the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after use of docetaxel (marketed by Sanofi as Taxotere).
According to the EMA, Xtandi is able to improve the survival of patients and to delay progression of the disease.
If approved by the EC, it will compete with Janssen’s Zytiga (abiraterone), which recently had its licence extended to cover mCRPC in men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
The need for more prostate cancer treatments is urgent, however, and Xtandi was approved under priority review in the US in September last 2012, three months earlier than expected.