FDA panel rejects J&J's new cancer drug

Cancer drugs are among the toughest and riskiest medicines to develop, because many of them offer only a small incremental benefit at a steep cost to patients and payers.

That's a lesson that that Johnson & Johnson and partner Zeltia are learning again today, after an FDA advisory panel voted to reject a new drug for ovarian cancer.

The panel said that risks of heart and liver toxicity outweight its ability to keep the disease in check, according to Reuters.

The panel voted 14-1 to recommend that the FDA reject the drug, called Yondelis. The FDA often follows the advisory panel's recommendations.

The panel also pointed out that the 6-week benefit in progression-free survival shown in a pivotal late-stage clinical trial did not justify approval.

Source : blogs.indystar.com

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