FDA questions J&J cancer drug data
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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 injectable drug Yondelis for women with recurring ovarian cancer. It would be used in combination with the company’s cancer drug Doxil.
But regulators said in briefings posted online yesterday that they are concerned the company’s results might not be reliable due to inconsistent interpretations of the data. Although the drug appears to slow the progression of cancer, it carries higher rates of toxic side effects.
J&J’s study relies on imaging scans designed to show a halt in progression of the cancer. But specialists hired to assess the images disagreed on what they showed 39 percent of the time, according to the FDA.
Drug developers routinely measure the amount of time it takes cancer to progress to prove the effectiveness of their drugs. But the FDA said the disagreement over the company’s results, “raises the question whether ‘progression-free survival’ could be reliably assessed in this clinical trial.’’
The FDA said it would ask its outside panel of cancer specialists to weigh in on the company’s findings. The agency often follows the advice of the panel, which will meet tomorrow, though it is not bound by it.
