MAA filed for Legend Biotech and Janssen's for cilta-cell in Europe

1 May 2021
legend_biotech_large

Legend Biotech (Nasdaq: LEGN), a clinical stage CAR-T immuno-oncology biotech being spun out of Hong Kong-listed GenScript Biotech, revealed on Friday that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) seeking approval of ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed and/or refractory multiple myeloma.

The request was ma Publishde by Legend’s collaborator, Janssen Biotech, a part of US healthcare giant Johnson & Johnson (NYSE: JNJ). In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, to develop and commercialize cilta-cel, which involved an upfront payment of $350 million.

Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy being investigated as a treatment for multiple myeloma. The MAA is based on positive results from a Phase Ib/II CARTITUDE-1 study.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Company News Directory



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology