Genetics and Health

European Union licenses bowel cancer drug AND companion diagnostic test

by Elaine on March 18th, 2008

I’ve known UK diagnostics company Lab-21 for some years now. My previous company Opaldia and Lab-21 effectively ‘grew up’ together. 

Amgen Limited UK and Lab21 have announced their partnership to introduce a new genetic therapy test for advanced bowel cancer treatment. Under the terms of the agreement, Lab21 will provide a screening test to indicate which patients are likely to benefit from Amgen’s new drug for advanced bowel cancer Vectibix® (panitumumab).

It is the first time that the European Commission (EU) has licensed a bowel cancer product with the stipulation that a predictive test should be carried out.  This is the start of companion diagnostics. The term companion diagnostic tests is used to describe diagnostic or prognostic tools that are specifically related to a therapeutic agent.

So I’m really pleased to see them link up with a visionary oncologist I’ve worked with for years - Dr Maurice Slevin at his London Oncology Clinic to introduce DXS’s KRAS pharmocogenetic test for advanced bowel cancer sufferers.

The KRAS gene is located on the short (p) arm of chromosome 12 at position 12.1.

 Source: NIH

Amgen scientists had discovered that only those patients with the non-mutated (wild type) KRAS would respond to Vectibix. Patients with metastatic bowel cancer will be tested for the presence of the wild type KRAS gene before they are prescribed the drug.

“It is particularly useful that Vectibix is being launched with a screening test for KRAS, which will help clinicians to target those patients most likely to benefit,”said Dr Maurice Slevin, “This means that patients unlikely to benefit will not receive a treatment which could expose them to unnecessary side-effects. Targeting cancer treatments is critical for the future if society is going to afford the ever increasing cost of innovative drugs.”

Approximately 60 per cent of patients with advanced bowel cancer have wild type KRAS. Of these, up to 60 per cent would be expected to respond to Vectibix.

Elaine Warburton  www.geneticsandhealth.com

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POSTED IN: Companion diagnostics, General Genetics and Health, Genetic Testing, Genetic legislation, Genetic risk, Genetics of Disease, Personalized Medicine, Pharmacogenetics, bowel-cancer, cancer