FDA Delays Decision on J & J Ovarian Cancer Drug

Fri, 09/11/2009 - 5:06am
HORSHAM, Pa. (AP) — A unit of Johnson and Johnson said Thursday federal health regulators want more information on its experimental treatment for ovarian cancer before making an approval decision. J&J said the Food and Drug Administration requested more data, including overall survival rates from patients enrolled in an ongoing company study. "The company is reviewing the FDA's letter and will respond to the agency's questions as quickly as possible," said the company's Centocor Ortho Biotech division, in a statement. In July the FDA's oncology panel voted 14-1 against the injectable drug, called Yondelis, which J&J hopes to market as a treatment for women with recurring ovarian cancer. It would be used in combination with the company's cancer drug Doxil. The panel said the drug's benefits did not outweigh its risks, including blood toxicity, anemia and heart problems. The FDA is not required to follow the group's advice, though it usually does. In a preliminary review released ahead of the meeting, FDA said it was considering whether to wait for more data on survival rates before making a decision on the drug.



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