The Cancer Letter

The leading source for information on the issues that shape oncology since 1973

Drugs & Targets

Amgen submits expanded application for Kyprolis in the EU

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print
BYLINE
IN THIS ISSUE
DOWNLOAD PDFTABLE OF CONTENTS

Amgen submitted a variation to its Kyprolis marketing authorization application to the European Union, to include a combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The application is based on results from the phase III head-to-head ENDEAVOR study in which patients with multiple...

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe
Table of Contents

YOU MAY BE INTERESTED IN

News Analysis

HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down
The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

Recently, HHS Secretary Robert F. Kennedy Jr. posted a video montage featuring himself shirtless in jeans, working out with Kid Rock. The duo is in a blue-lit grotto with a cold plunge and sauna. Set to Kid Rock’s “Bawitdaba” and intercut with a selection of patriotic imagery, the video ends with the two men in a hot tub, chugging what appears to be milk.
By Claire Marie Porter
Guest Editorial

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.” This release came roughly 20 months after the Oncologic Drugs Advisory Committee (ODAC) voted unanimously that minimal residual disease (MRD) negativity, in combination with complete response (CR), is an acceptable primary endpoint to support accelerated approval for multiple myeloma (MM) therapies. 
By Nicholas Richardson
Table of Contents

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login

Site license subscribers:
Log in with your IP | Register a sponsored account