NCI Expert Drafts Roadmap For Metastasis-Prevention Trials
National Cancer Institute’s Patricia Steeg highlights “huge barrier” for developing drugs that prevent breast cancer metastases but don’t work on traditional tumor shrinkage endpoints. She urges new guidance from FDA and input from the oncology community to pave the way for promising drugs.
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As expected, FDA rejected the new indication for Amgen’s bone drug Xgeva in prevention of bone metastases. But the door is still open for other therapies for castration resistant prostate cancer to target earlier stages of disease.
Measurement of a downstream endpoint, such as delay in skeletal-related events, could have been better than radiographic scans to assess efficacy of denosumab in delaying bone metastases in high-risk castration-resistant prostate cancer patients, several ODAC members contend.
The five-year I-SPY 2 study is a model for drug development and an innovative screening process for identifying winners, FDA's Woodcock says.