Personalised medicine advanced with TGA approval of bowel cancer treatment

Many are heralding that personalised medicine - where treatments are tailored to the individual genetic characteristics of the patient - to be the future of therapeutics.

That vision got a boost today with the tick of approval from the Therapeutic Goods Administration (TGA) being given to the treatment of metastatic bowel cancer, Erbitux, marketed by Merck Serono.

Erbitux will be used in conjunction with chemotherapy for patients who have the KRAS biomarker wild type metastatic bowel cancer.

Studies have shown the presence of the KRAS biomarker is a strong predictor of whether the patient will respond to treatment.

“The TGA’s approval of Erbitux is a significant step forward for the treatment of Australians with advanced bowel cancer,” said Dr Chris Karapetis, the leader of a large global trial of Erbitux being driven out of Flinders University in Adelaide.

“Trial results provide important clinical evidence that treatment of bowel cancer can be personalised, with the KRAS biomarker identifying which patients are most likely to benefit from treatment with Erbitux. Such an approach helps focus the treatment on those patients that have the greatest chance of benefiting,” he said in a statement.

The TGA approval comes on the back of results from two recent clinical trials, one, called Crystal, which was published in the New England Journal of Medicine, and the other, called Celim, published in Lancet Oncology.

Crystal demonstrated that Erbitux with chemotherapy significantly reduced the growth and spread of the cancer. Celim, a phase II study, found that Erbitux and chemotherapy also significantly benefited patients for whom the cancer had spread to the liver, with 46 per cent of this with previously inoperable tumours able to undergo surgical removal after treatment, and nearly three quarters of these being tumour-free following surgery.

Merck Serono has also applied to have Erbitux listed on the Pharmaceutical Benefits Scheme, which is currently being considered by the Pharmaceutical Benefits Advisory Commission.