Abbott's prostate cancer drug, Xinlay, turned down by FDA panel

In what is seen as a serious setback for Abbott Laboratories, the Oncology Drug Advisory Committee (ODAC) to the US Food and Drug Administration (FDA) advised against the approval of Xinlay (atrasentan), an experimental drug for prostate cancer. Abbott was hoping Xinlay would become a blockbuster (big-selling drug). The panel were concerned about lack of clear efficacy evidence, they also wondered about its cardiovascular safety.

The panel, in its report, mentioned some protocol violations.

Abbot disagreed, saying the benefits are great while the safety profile is manageable.

Abbott says it is hopeful the FDA's final decision may be different. Historically, the agency tends to go by what the panel has recommended.

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