Page URL:

Lung cancer gene test approved as 'companion diagnostic'

20 May 2013
Appeared in BioNews 705

The US medicines regulator, the Food and Drug Administration (FDA), has approved a genetic test to help doctors select suitable lung cancer patients to be treated with the drug erlotinib (sold as Tarceva).

The diagnostic from Roche is the first licensed test for variants of the EGFR gene, which encodes the protein that erlotinib targets.

Dr Hal Barron, head of global product development at Roche says that 'ten to 30 percent of people worldwide with lung cancer have tumours that test positive for certain EGFR mutations'.

The test will be used to check whether patients with advanced, metastatic cancer – where the cancerous cells have spread to other parts of the body – have one of these mutations. If they do, then they are more likely to benefit from erlotinib in place of standard chemotherapy.

The EURTAC clinical trial validated this approach. In the study, patients with EGFR mutations treated with erlotinib lived for over ten months without their getting worse. In comparison, patients given standard chemotherapy lived without disease progression for only five months.

These non-small cell lung cancers (NSCLC) account for the majority of lung cancers, which themselves account for the majority of the cancer-related deaths. Personalised medicine regimes such as this aim to tailor drug courses to those patients for whom the drugs are most likely to be effective. It is hoped that this will provide better outcomes for patients, while using restricted healthcare funds more cost-effectively.

Erlotinib has been licensed in the UK and elsewhere in Europe as first-line treatment of NSCLC in patients harbouring appropriate EFGR mutations since 2012, after the EURTAC trial showed it to be effective. It is also indicated as a potential second-line treatment where previous chemotherapy courses have failed.

FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer
US Food and Drug Administration (press release) |  14 May 2013
FDA approves Roche diagnostic for gene mutation in lung cancer
Reuters |  14 May 2013
FDA Approves Roche EGFR Mutation CDx for NSCLC
Genetic Engineering and Biotechnology News |  15 May 2013
FDA approves Tarceva (erlotinib) tablets and cobas EGFR Mutation Test for specific type of lung cancer
Roche (press release) |  15 May 2013
Roche Wins FDA Approval for Test to Target Lung Cancer
Bloomberg |  15 May 2013
15 September 2014 - by Antony Starza-Allen 
Scientists have shown that minimal genetic changes can be detected in vapour containing cells engineered to replicate early stage lung cancer....
2 December 2013 - by Ruth Saunders 
The US Food and Drug Administration has ordered 23andMe to 'immediately discontinue' its Personal Genome Service after failing to undergo proper agency approval for its marketing claims...
28 May 2013 - by Dr Shanya Sivakumaran 
A genetic testing programme that will look for nearly 100 cancer risk genes has been launched, in the hope that genetic tests will become routine for cancer patients across the UK....
5 November 2012 - by Maria Sheppard 
A drug which prolongs life in a form of skin cancer associated with a genetic mutation has been recommended for use on the NHS...
17 September 2012 - by James Brooks 
Genetic tests that could greatly improve the effectiveness of drug therapy for a wide variety of conditions are being underused or ignored, a leading expert says...
20 August 2012 - by Ruth Saunders 
23andMe, a US-based personal genomics company, has sought regulatory approval from the Food and Drug Administration for seven of its genetic tests....
19 December 2011 - by Nishat Hyder 
A patent for a diagnostic test is currently under consideration by the US Supreme Court. The eventual decision may have profound implications for the burgeoning 'personalised medicine' industry which often relies on DNA tests to guide physicians in choosing tailored therapies for patients...
to add a Comment.

By posting a comment you agree to abide by the BioNews terms and conditions

Syndicate this story - click here to enquire about using this story.