FDA approves Erbitux test for launch by BMS, Eli Lilly

Every week FierceBiomarkers reports on new genetic mutations with potential to pick out patients who could benefit from this drug or that, and it seems that many of these are just pie in the sky--nice science but the practical application is still many years away. Now, the FDA has approved Qiagen's ($QGEN) genetic biomarker-based therascreen KRAS RGQ PCR Kit. This test can pick out the metastatic colon cancer patients who are most likely to respond to Erbitux (cetuximab), and this will be launched by Bristol-Myers Squibb ($BMY) and Eli Lilly ($LLY). Erbitux, first approved in 2004 and marketed by BMS and Lilly, is not effective in people with one of 7 mutations in the KRAS gene, and Qiagen's test is designed to detect these variants.

The approval was based on an evaluation of samples from clinical trials. At the same time, the FDA also approved Erbitux for the first-line treatment of metastatic colorectal cancer in combination with the FOLFIRI chemotherapy regimen.

"The approval of this new Erbitux indication with the concurrent approval of a genetic test provides clear guidance on selecting patients who will optimally benefit," said Richard Pazdur, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

According to the American Cancer Society, there were more than 141,000 new colorectal cancer cases in the U.S. in 2011. Qiagen believes that these patients could benefit from the test, and its use could save more than $600 million in unnecessary therapeutics.

This is the first FDA approval of a Qiagen diagnostic, though its tests are already available in Europe and Asia, and the company predicts annual sales of $20 million in the U.S. According to Zacks Equity Research, this product fits well into Qiagen's portfolio, though the company is facing growing competition in this field.

- read the press release  from the FDA
- see the press release from Qiagen
- check out the blog post from Zacks Equity Research