A.M. Vitals: FDA Panel Votes to Strip Avastin’s Breast Cancer Indication

Published On: July 21st, 2010

Also: Harvard Med School tightens its rules on faculty-industry involvement; WellPoint exec leaves; Chamber of Commerce sets up health-overhaul complaint site.

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A.M. Vitals: FDA Panel Votes to Strip Avastin’s Breast Cancer Indication

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A.M. Vitals: FDA Panel Recommends Pulling Avastin’s Breast-Cancer Approval
Avastin Vote: An FDA appeals panel made up of outside experts voted 6-0 to recommend the agency remove Avastin’s approval for breast cancer, the WSJ reports . Panel members said studies showed the Roche drug provided no meaningful benefit to patients while raising the risk for serious side effects. ..
FDA Proposes Removing Avastin’s Breast-Cancer Indication
European regulators, meantime, recommended the drug still be used in breast-cancer patients, but only in combination with one form of chemo. ..
A.M. Vitals: FDA Advisory Panel Votes Against Novartis’s Gout Drug
Drug Vote: An FDA advisory panel voted not to recommend approval of Novartis’s Ilaris for gout pain, though it did say the drug is effective, the WSJ reports . ..
A.M. Vitals: FDA Advisory Panel Votes Against Drugs as Prostate-Cancer Preventatives
Also: food-safety bill hits a snag; Allergan seeks broader (though thinner) audience for Lap-Band; PhRMA dollars; Merck bets on experimental insulin product. ..
A.M. Vitals: FDA Panel Votes Against Diabetes Drug From Bristol, Astra
Drug Vote: An FDA advisory panel voted 9-6 against approving dapagliflozin, a new type of diabetes drug from Bristol-Myers Squibb and AstraZeneca, saying more information is needed on possible risks including breast and bladder cancers, the WSJ reports . Some panel members, however, said teasing out those possible safety problems would be best accomplished not..
A.M. Vitals: FDA Appeals Panel to Hold Avastin Hearing This Week
Avastin Arguments: At an FDA appeals hearing tomorrow and Wednesday, Roche’s Genentech unit will argue that the conditional approval for its drug Avastin to be used against breast cancer shouldn’t be pulled, despite evidence showing it doesn’t help patients live any longer and carries the risk of serious side effects, the WSJ reports . FDA..

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