Testing colorectal cancer patients for their UGT1A1*28 status before prescribing irinotecan is cost-effective only when reduced doses of the drug are as effective as full doses in patients who are homozygous for the variant.
In order to make the labeling change, the agency reviewed retrospective data from seven clinical trials. But this is the exception, according to one official from a diagnostic company who believes FDA's lengthy deliberations have further nudged drug companies to advance diagnostics at the same time as therapeutics in prospective studies.
The FDA has updated the drugs' labels to note that "retrospective analyses of metastatic colorectal cancer trials have not shown a treatment benefit for the EGFR inhibitors in patients whose tumors had KRAS mutations in codon 12 or 13" and that the use of the drugs is not recommended for the treatment of colorectal cancer patients with these mutations.
Even though Genomic Health's Oncotype DX recurrence test for colorectal cancer failed to meet its chemotherapy benefit endpoint, investment group Thomas Wiesel is optimistic after a survey of 47 physicians and researcher that the strength of the Oncotype DX brand and the lack of molecular profiling options in the colorectal cancer setting will drive adoption of the test.
Exact gained exclusive rights to technology developed by the Mayo Clinic's David Ahlquist relating to sample processing, analytical testing, and data analysis for non-invasive, stool-based DNA screening for colorectal cancer.
CEO David Deems said that Xceed has decided to engage the FDA early in the development process because the agency's "thinking on these types of tests is evolving" and the company would like to "stay connected to whatever approach they are thinking of putting in place."