Citing failed studies, FDA rejects breast cancer drug

The Takeaway

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After an emotional and tense two-day hearing in Silver Springs, Md., federal advisers voted to revoke the approval of the world’s top-selling cancer drug Avastin as a treatment for women with advanced breast cancer. The Food and Drug Administration’s Oncologic Drugs Advisory Committee heard from patients who say Avastin is a miracle drug, and from cancer advocates who point to adverse side-effects in other users. Finally, the committee concluded that research showed that the drug, which costs $88,000 a year per patient, failed to significantly extend patients’ lives or their quality of life.

Heraleen Broome, from Oakland, California, who has been on the drug for eight years, testified at the hearing. She says the decision is tantamount to issuing her with a “license to die.”

According to the FDA website, the advisers’ decision related to breast cancer, “will not affect Avastin’s approved indications for use in colon, lung, kidney, and brain cancers.”

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“The Takeaway” is a national morning news program, delivering the news and analysis you need to catch up, start your day, and prepare for what’s ahead. The show is a co-production of WNYC and PRI, in editorial collaboration with the BBC, The New York Times Radio, and WGBH.

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