Regulatory Focus™ > News Articles > Companion Diagnostic Test, Drug Get Concurrent Approval from FDA

Companion Diagnostic Test, Drug Get Concurrent Approval from FDA

Posted 09 July 2012 | By Alexander Gaffney

A companion diagnostic test developed by Manchester, England-based QIAGEN and marketed by Bristol-Myers Squibb and Eli Lilly and Company has won approval from the US Food and Drug Administration (FDA) for determining whether the anti-colorectal cancer (CRC) drug Erbitux (cetuximab) will be effective in patients.

The product, known as the Therascreen KRAS RSQ PCR Kit, screens patients for the presence or absence of a particular mutation in the KRAS gene. If the KRAS gene mutation is absent, then Erbitux is likely to be effective in patients with CRC.

In approving the product, FDA also approved Erbitux for use in combination with a class of chemotherapy drugs known as FOLFIRI (irinotecan, 5-fluorouracil, and leucovorin), which are used as a first-line treatment in patients with metastatic CRC without the KRAS gene mutation.

"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, MD, director of the Office of Oncology Drug Products in FDA's Center for Drug Evaluation and Research. "Clinical trial data leading to the approval of this new indication supports the recommendation to treat those patients whose colorectal tumors do not have KRAS mutations and to avoid treating those with KRAS mutations."

Erbitux, then developed by biotech company ImClone--now owned by Eli Lilly-- was originally cleared by FDA in 2004 for the treatment of EGFR-expressing metastatic colorectal carcinoma. The drug's label has been updated a dozen times since its original approval, including a 2009 update after FDA determined the drug was not effective in patients with the KRAS gene mutation.


Read more:

FDA - FDA approves genetic test to help some colon cancer patients, physicians considering Erbitux therapy

Erbitux Approval History


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