Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News Merck Serono receives CHMP backing for Erbitux label update

Merck Serono receives CHMP backing for Erbitux label update

26th November 2013

Merck Serono has been granted a European regulatory recommendation for a proposed update to the label of its colorectal cancer drug Erbitux.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on a variation to Erbitux's product information, updating the assessment of the drug's benefit-risk profile.

This would allow the therapy to be used in the treatment of patients with RAS wild-type tumours, after data from the Opus study suggested Erbitux could offer benefits to those in this category.

Meanwhile, results from the phase III head-to-head clinical trial Fire-3 presented last month showed that Erbitux plus Folfiri can provide a 7.5-month increase in median overall survival rates compared to another therapy for the same condition.

Dr Annalisa Jenkins, head of global research and development for Merck Serono, said: "We are pleased with this important evolution of the label for Erbitux, based upon new emerging data from our previous and ongoing studies of patients living with colorectal cancer."

Merck Serono's drug has now been approved for the treatment of colorectal cancer in 93 countries and for the treatment of squamous cell carcinoma of the head and neck in 91 nations.ADNFCR-8000103-ID-801665012-ADNFCR

We currently have 9 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.