A part of Watch Media

MedWatchSaturday28 January 2023

  • Search
  • Log in
  • Pharma & biotech
  • Medtech
  • Hearing health
  • Regulation
  • Other
  • Search
  • Log in
  • Latest
  • Search
  • Log in
  • Pharma & biotech
  • Medtech
  • Hearing health
  • Regulation
  • Other
21/05/2021at 15:54

EMA gives positive opinion on Genmab's Darzalex in combination treatment

On Friday, Genmab came one step closer to receiving EU approval for a rare blood disorder.
Photo: Joost Melis / Genmab / PR
BY MIKKEL AABENHUS HEMMINGSEN, TRANSLATED BY NIELSINE NIELSEN

The European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends that Genmab's Darzalex be authorized for use in combination with cancer treatment Velcade and drugs cyclophosphamide and dexamethasone for treating adults with systemic light-chain (AL) amyloidose.

This recommendation encompasses the injection-based version of Darzalex which is marketed as Darzalex SC in the EU and as Darzalex Faspro on other markets, according to a Genmab press release on Friday afternoon.

Aside from the treatment of AL amyloidosis, the CHMP also recommends that Darzalex SC is used in combination with celgene's imnovid and dexamenthason for treating patients with multiple myeloma who have received at least one prior therapy containing a proteasome inhibitor (PI) and lenalidomide, or who have demonstrated disease progression in spite of having received at least two prior therapies that included lenalidomide and a proteasome inhibitor (PI).

Formally, the application for EU marketing authorization was submitted by Genmab's official partner Janssen.

Genmab CEO on legal fight with Janssen: Standing up straight and fighting for what's morally and ethically right 

Analysts to home in on expenses in Genmab's Wednesday fiscal report 

Janssen had better Darzalex sales than expected in Q1 

Genmab CEO on possible settlement in dispute with Janssen: "I have no comment" 

Related articles:

  • Photo: Mik Eskestad/ERH

    Genmab CEO on legal fight with Janssen: Standing up straight and fighting for what's morally and ethically right

    For subscribers

  • Photo: Tuala Hjarnø / Genmab / PR

    Analysts to home in on expenses in Genmab's Wednesday fiscal report

    For subscribers

  • Photo: Joost Melis / Genmab / PR

    Janssen had better Darzalex sales than expected in Q1

    For subscribers

Sign up for our newsletter

Stay ahead of development by receiving our newsletter on the latest sector knowledge.

!
Newsletter terms

Front page now

Foto: Rob Acket/ema
Regulation

CHMP recommends four drugs in January

Bristol Myers Squibb’s Sotyktu, a treatment for moderate-to-severe psoriasis in adults, has gained the favor of the EMA’s expert committee, alongside three generics.
  • CHMP recommends expanded approval of Dupixent
  • Denmark rejects Janssen and Genmab drug twice in January

For subscribers

Klaus Holse is chairman of the Confederation of Danish Industry and board member of at tech firm Terma – both roles with ties to William Demant Invest CEO Niels Jacobsen | Foto: Pr / Dansk Industri
Hearing health

Proposed GN board member has ties to William Demant Invest CEO – GN dismisses connection

For subscribers

Maiken Riise Andersen, ALK's new head of communications and media relations | Foto: Jørgen True, Studie-e
Pharma & biotech

New ALK head of communications to draw in new hires

For subscribers

Foto: GN Store Nord / PR
Hearing health

Analyst: Chairman exit increases chance of GN-Demant merger

For subscribers

Foto: MedWatch
Other

Top news from MedWatch this week

EMA's hovedkvarter i Amsterdam. | Foto: Rob Acket/ema
Pharma & biotech

EMA says antibiotic shortage situation isn't "major event"

For subscribers

Further reading

Foto: Novo Nordisk / Pr
Pharma & biotech

FDA approves Novo Nordisk's Rybelsus as first-line treatment option

Rybelsus, the tablet formulation of semaglutide, has now been approved in the US as a first-line treatment option for adults with type 2 diabetes.

For subscribers

Klaus Holse is chairman of the Confederation of Danish Industry and board member of at tech firm Terma – both roles with ties to William Demant Invest CEO Niels Jacobsen | Foto: Pr / Dansk Industri
Hearing health

Proposed GN board member has ties to William Demant Invest CEO – GN dismisses connection

GN’s proposed board member, Klaus Holse, runs in the same board circles as the CEO of William Demant Invest – but GN says the pick is unrelated to ”any conceivable or inconceivable acquisition.”

For subscribers

Foto: Coloplast / Pr
Medtech

Coloplast is the world's most sustainable medtech firm in new analysis

Among 87 of the largest, publicly listed medtech companies, Coloplast has been deemed the very best on sustainability, according to a new international ranking. 

For subscribers

Latest news

  • Top news from MedWatch this week – 27 Jan
  • CHMP recommends four drugs in January – 27 Jan
  • Denmark rejects Janssen and Genmab drug twice in January – 27 Jan
  • New ALK head of communications to draw in new hires – 27 Jan
  • CHMP recommends expanded approval of Dupixent – 27 Jan
  • Proposed GN board member has ties to William Demant Invest CEO – GN dismisses connection – 27 Jan
  • EMA says antibiotic shortage situation isn't "major event" – 27 Jan
  • Analyst: Chairman exit increases chance of GN-Demant merger – 27 Jan
  • AGC Biologics to produce Eli Lilly-developed drug delaying type 1 diabetes – 26 Jan
  • Per Wold-Olsen's retirement is "a great loss for GN" – 26 Jan
See all

Jobs

  • Experienced Patent Counsel

  • Commercial Director

  • Head of International Sales

  • Principal Laboratory Technologist

  • Lead Data Architect

  • Two department leaders for the Department of Pharmacy and the Department of Drug Design and Pharmacology

  • Senior Regulatory Affairs Professional

  • Clinical Operational Associate

  • Application Manager

  • Specialist for the supply of pharmaceuticals to Danish hospitals

  • Head of Regulatory Affairs Danmark

  • Application Manager

  • Sr. Director, Drug Safety Physician

See all jobs

Jobs

  • Experienced Patent Counsel

  • Commercial Director

  • Head of International Sales

  • Principal Laboratory Technologist

  • Lead Data Architect

  • Two department leaders for the Department of Pharmacy and the Department of Drug Design and Pharmacology

  • Senior Regulatory Affairs Professional

  • Clinical Operational Associate

  • Application Manager

  • Specialist for the supply of pharmaceuticals to Danish hospitals

  • Head of Regulatory Affairs Danmark

  • Application Manager

  • Sr. Director, Drug Safety Physician

See all jobs

Colophon

MedWatch
Search

Sections

  • Pharma & biotech
  • Medtech
  • Hearing health
  • Regulation
  • Other
  • Sitemap
  • RSS feeds

Editor

Mikkel Aabenhus Hemmingsen

mah@medwatch.dk

Tel.: +45 3330 8387

Editor-in-chief

Anders Heering

Publisher

JP/Politiken Media Group Ltd

Advertising

annoncering@infowatch.dk

Tel.: +45 7077 7441

Advertising

Job Advertising

job@infowatch.dk

Tel.: +45 7077 7441

Jobs

Subscription

Try MedWatch or get an offer for a subscription meeting the exact needs of you or your company.

medwatch@infowatch.dk

Tel.: +45 7077 7441

Learn more about subscriptions here

Address

MedWatch

Rådhuspladsen 37

1785 Copenhagen K, Denmark

Tel.: +45 3330 8370

Guidelines

  • Privacy Policy

Copyright © MedWatch — All rights reserved

Microsoft is in the process of discontinuing Internet Explorer – and so are we.
For a better experience, we recommend using one of the following browsers.

Kind regards,
MedWatch

Google ChromeMozilla FirefoxMicrosoft Edge