Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Janssen looks to win new indication in Europe for Imbruvica for untreated mantle cell lymphoma 

By Brian Buntz | March 9, 2022

JanssenJohnson & Johnson‘s Janssen unit (NYSE:JNJ) has filed a submission of a Type II variation application to the European Medicines Agency (EMA) for the potential approval of Imbruvica (ibrutinib) with bendamustine and rituximab (BR) to treat adults with previously untreated mantle cell lymphoma (MCL).

The indication would cover patients who are not suitable for autologous stem cell transplantation (ASCT).

Bendamustine is a chemotherapy drug while and rituximab is a monoclonal antibody that slows or stops cancer growth.

JNJ shares ticked up 0.38% to $169.36 today.

Ibrutinib was jointly developed by J&J’s Janssen Biotech unit and Pharmacyclics LLC, an AbbVie company.

Imbruvica

Image courtesy of Janssen

In the U.S, the drug first won approval for mantle cell lymphoma in 2013. The drug has won a series of new indications since then.

A daily Bruton’s tyrosine kinase (BTK) inhibitor, Imbruvica, is now indicated in Europe for MCL patients who have had at least one prior treatment.

An incurable blood cancer, MCL frequently requires multiple lines of treatment.

“Mantle cell lymphoma can be a difficult blood cancer to treat, and despite progress in this area over the last few years, an unmet need remains for new treatment approaches,” said Dr. Edmond Chan, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited, in a statement.

As part of the submission, Janssen included data from the Phase 3 SHINE study (NCT01776840), which met its primary endpoint of progression-free survival.

Imbruvica generated $9.4 billion in revenue in 2020.


Filed Under: Oncology
Tagged With: Janssen, Johnson & Johnson, mantle cell lymphoma, MCL
 

Tell Us What You Think! Cancel reply

You must be logged in to post a comment.

Related Articles Read More >

Novartis in the Pharma 50
Novartis announces tislelizumab helped extend median overall survival in first-line advanced esophageal cancer 
Johnson & Johnson Janssen pharmaceutical business in the Pharma 50
Janssen gets positive CHMP opinion for Imbruvica for adults with untreated chronic lymphocytic leukemia
oncopeptides
Oncopeptides’ Pepaxti wins positive opinion from CHMP for multiple myeloma patients
DNA sequencer
Localizing next-generation sequencing testing for cancer patients

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50