In Vivo 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

UsernamePublicRestriction
UsernamePublicRestriction

This Isn't The Big One: Darzalex Wins US Approval In First-Line Multiple Myeloma

Executive Summary

Janssen Biotech has won FDA approval for Genmab-licensed Darzalex in newly diagnosed multiple myeloma. However, the drug was approved in a combination that is not commonly used in the US. A further label expansion will provide a bigger boost to the anti-CD38 antibody's commercial prospects.

You may also be interested in...



Sanofi Poised To File Isatuximab In Multiple Myeloma, Going Up Against J&J's Darzalex

Isatuximab could be the next building block in Sanofi's ambitions to rebuild in oncology. The CD38-targeting antibody extended PFS in relapsed/refractory multiple myeloma in combination with Celgene's Pomalyst and dexamethasone.

Keeping Track: A CRL For Tlando, An Accelerated Approval For AndexXa, And A Burst Of Supplemental Approvals

The latest US drug development news and highlights from our Performance Tracker.

New Mechanism And Oral Activity Underline Selinexor's Role In Multiple Myeloma

Karyopharm has reported positive top-line Phase IIb data from the STORM study showing the potential benefits of its orally active lead compound, selinexor, in "penta-refractory" multiple myeloma, and is aiming for rapid approval of the first-in-class agent in the US and Europe.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC142523

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