Roche has been requested to provide additional clinical data on its skin cancer therapy Zelboraf to support a potential recommendation of the drug by the National Institute for Health and Clinical Excellence (NICE).
The UK regulator has asked the company to make further information available that demonstrates the benefits of Zelboraf for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma.
“Roche has been asked to provide more information on its skin cancer drug Zelboraf to NICE in order to support a potential recommendation for the product.“
Key to this process will be Roche's ability to prove that the drug is a cost-effective means of treating this form of cancer, and offers enough long-term benefits to be worth funding via the NHS.
Professor Carole Longson, health technology evaluation centre director at NICE, said: "We hope that Roche will be able to provide this additional information so that the committee can consider it at its next meeting on the topic."
The successful launch of Zelboraf in Europe earlier this year has been cited by Roche as a business highlight and driver of growth in the first half of 2012, a period that saw the firm experience a three percent year-on-year increase in sales.