Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

Amgen Buries Second FDA Action Letter For Bone Drug in Cancer Indications

This article was originally published in The Pink Sheet Daily

Executive Summary

HALT! More bad news: Complete Response letter from Agency this week requests new studies in treatment induced bone loss.

You may also be interested in...



New Oncology Indications Should Continue Denosumab’s Upward Trajectory

Already on an upward trajectory in oncology uses, Amgen’s denosumab, known as Prolia and Xgeva, got a bit of a boost with FDA approval of two new indications for treatment-induced bone loss in prostate and breast cancer – though neither is expected to add much to the bottom line.

New Oncology Indications Should Continue Denosumab’s Upward Trajectory

Already on an upward trajectory in oncology uses, Amgen’s denosumab, known as Prolia and Xgeva, got a bit of a boost with FDA approval of two new indications for treatment-induced bone loss in prostate and breast cancer – though neither is expected to add much to the bottom line.

New Oncology Indications Give Amgen's Bone Drug Denosumab A Bit Of A Leg Up

Concerns laid out in "complete response" letter were addressed with data from other trials.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS068637

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

Cancel