Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA Approves Amgen's Denosumab For First Oncology Indication

This article was originally published in The Pink Sheet Daily

Executive Summary

Known as Prolia for osteoporosis, the drug will be called Xgeva for skeletal-related events related to metastasized solid-tumor cancers.

You may also be interested in...

Amgen’s Xgeva Gains FDA Nod For Use In Rare Bone Tumor

Approval of denosumab for giant cell tumor of the bone comes more than a year after Amgen’s failed bid to add a more commercially significant indication for prevention of bone metastases in patients with castrate-resistant prostate cancer.

Xgeva Comes Up Short On Clinical Benefit, Has Too Much Risk, ODAC Tells FDA

The oncologic drugs panel rejects an expanded indication for Amgen’s denosumab, saying a 4.2-month delay in progression of bone metastasis in castrate-resistant prostate cancer patients does not offset the risk of osteonecrosis of the jaw.

Xgeva Prostate Cancer Claim May Not Benefit Beyond Existing Cancer Indication, FDA Says

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.

Related Content





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts