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.
Without PGx-guided dosing information, it is unclear whether genetic testing to gauge Plavix response will go the same way as genetic testing for warfarin. At least one national insurer, Aetna, feels that the FDA did not provide enough information in the updated label to warrant coverage for the intervention.
The International Brotherhood of Electrical Workers launched its Stop Biotech Looting campaign last week after learning that subcontractors have been hiring non-union workers over the past year on a half-dozen projects for Boston-area life-sci giants.
The Massachusetts Life Sciences Center has approved spending a combined $2.5 million of the $1 billion, 10-year Life Sciences Act to subsidize life-sci companies that hire paid college-level interns, and to fund younger researchers.
NHLBI plans to launch next month the prospectively designed, randomized-controlled study, called Clarification of Optimal Anticoagulation through Genetics trial, which will follow 1,200 patients to see if PGx-guided dosing is clinically useful.