Amgen’s Xgeva For Castration-Resistant Prostate Cancer Faces Panel Review Without Overall Survival Advantage
This article was originally published in The Pink Sheet Daily
Delaying or preventing bone metastasis is an important clinical benefit for patients, an FDA official said recently. The Oncologic Drugs Advisory Committee will share its opinion about the product on Feb. 8.
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The agency will ask the Oncologic Drugs Advisory Committee whether delaying bone metastases in high-risk castrate-resistant prostate cancer patients provides benefit above that obtained with current use of t drug to delay skeletal-related events and is worth a potentially higher risk for osteonecrosis of the jaw.
Company’s announcement that it pulled the NDA for its investigational non-Hodgkin’s lymphoma treatment comes after the sponsor would have received FDA’s background briefing document for the Feb. 9 Oncologic Drugs Advisory Committee meeting.
ApoPharma's transfusional iron overload treatment has been approved in Europe since 1999, but FDA sent a "complete response" letter in 2009.