WASHINGTON - Food and Drug Administration scientists are questioning whether study results are reliable enough to warrant approval for a new cancer drug from Johnson & Johnson.
J&J's Ortho Biotech unit has asked the FDA to approve the injectable drug Yondelis for women with recurring ovarian cancer. It would be used with J&J's cancer drug Doxil.
But regulators are concerned the company's results may not be reliable because of a large number of inconsistencies.
The company's data use imaging scans designed to show a halt in progression of the cancer. But radiology experts hired by J&J disagreed on what the images showed 39 per cent of the time.
The FDA's outside cancer experts will weigh in on the results Wednesday.
