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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 the 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 briefing documents posted online Monday that they are concerned the company's results may not be reliable due to inconsistent interpretations of the data. While the drug appears to slow the progression of cancer, it also 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 experts 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 experts to weigh in on the accuracy, reliability and relevance of the company's findings. The agency often follows the advice of the panel — which will meet Wednesday — though it is not required to.
J&J studied the drug in 673 women whose cancer returned after treatment with chemotherapy drugs.
Patients taking Yondelis and Doxil together lived an average of 7.3 months without seeing their cancer progress, compared with 5.8 months for those taking Doxil alone. The FDA plans to ask its outside experts whether that six-week benefit is significant enough to outweigh Yondelis' risks.
Patients taking Yondelis were more likely to have blood toxicity, anemia and heart problems, according to the FDA's review.
Given the potential side effects and lingering questions about the drug's effectiveness, the FDA plans to ask its experts whether it should wait for more data on survival rates before making a decision on the drug.
More than 15,000 women in the U.S. died from ovarian cancer last year, according to the National Cancer Institute. Less than half of patients diagnosed with the cancer live beyond five years.
"We believe these therapies may provide important new treatment options for patients by addressing serious unmet medical needs," J&J spokeswoman Lisa Vaga said in a statement.
Ortho Biotech developed Yondelis in cooperation with Spanish drugmaker PharmaMar, which holds marketing rights in Europe and Japan. Ortho Biotech holds rights for the rest of the world. The drug is a manmade version of a chemical found in the tunicate, a saclike underwater animal found in the Caribbean.
