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The validity of claims made by Johnson & Johnson for a new cancer drug have been questioned in the US by the Food and Drug Administration (FDA).
The company is seeking approval for the injectable drug Yondelis, which is intended for use in combination with the approved cancer drug Doxil for women with recurring ovarian cancer.
But the FDA has questioned whether study results are reliable. It notes that although Yondelis appears to slow the progression of cancer, it also carries higher rates of toxic side effects.
A J&J trial relied on imaging scans designed to show a halt in progression of the cancer. But experts have reportedly disagreed with J&J`s findings 39% of the time.
The FDA says that the disagreement “raises the question of whether “progression-free survival” could be reliably assessed in this clinical trial”.
As a result, it is to ask its outside panel of experts to assess on the accuracy, reliability and relevance of the company’s findings. The agency often follows the advice of the panel, although it is not required to do so.
Copyright Press Association 2009