NICE approves Erbitux for colon cancer
pharmafile | June 1, 2009 | News story | Research and Development, Sales and Marketing | Erbitux, NICE
NICE has approved Merck Serono's Erbitux, making it a first-line therapy for many patients with a certain type of metastatic colorectal cancer.
It marks the increasing success of the ascendant oncology drug, and will also help it stay ahead of its rival Amgen's Vectibix.
Dr Wolfgang Wein, executive vice president of oncology at Merck Serono, said: "This is the second positive NICE recommendation for Erbitux in the last 12 months and represents really positive news for metastatic colorectal cancer patients in the UK – especially as Erbitux is the only targeted therapy endorsed by NICE for the first-line treatment of the disease."
Erbitux is a monoclonal antibody and one of a class of new cancer drugs, which target genetic mutations that allow cancer cells to multiply, and are designed to bypass many of the unpleasant side-effects associated with traditional chemotherapy.
NICE's Final Appraisal Determination recommended Erbitux in combination with chemotherapy as a first-line treatment for patients with metastatic (advanced) colorectal cancer (mCRC) who have met specific additional criteria.
Evidence submitted to NICE showed Erbitux's efficacy in mCRC patients with specific genetic make-up. These patients have what is known as KRAS wild-type tumours, and represent up to 65% of all patients with the disease.
Dr Wein added: "We strongly believe that personalising cancer care by tumour type through KRAS testing at diagnosis is essential in order to provide patients with the best possible outcomes – such as potentially curative surgery – while offering healthcare providers the most efficient use of resources."
More than 370,000 people develop colorectal cancer in Europe every year, accounting for 13% of the total cancer burden and around 200,000 deaths.
First developed by ImClone, Erbitux was launched by Merck in Europe five years ago as a second or third line treatment for metastatic colorectal cancer (mCRC). It gained first-line license last year in Europe.
The latest license from European regulators and the new approval by NICE will help its already strong position against Amgen's rival drug Vectibix, which though launched in the UK last year, is only licensed once other treatment regimes have failed.
The final NICE guidance is scheduled to be published in July and will be implemented within three months of publication.
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