BioCentury
ARTICLE | Regulation

The case for retrospection

December 22, 2008 8:00 AM UTC

Having fallen behind European regulators and U.S. clinical practice in stratifying cancer patients with K-Ras mutations for treatment with Erbitux and Vectibix, FDA last week convened an advisory panel meeting that gave it cover to accept retrospective biomarker analyses to support labeling.

By asking the Oncologic Drugs Advisory Committee to discuss the conditions under which a retrospective analysis would be appropriate, FDA was belatedly acknowledging the necessity of K-Ras testing before Erbitux cetuximab and Vectibix panitumumab can be prescribed for metastatic colorectal cancer (mCRC)...