FDA accepts Kyowa Hakko Kirin's BLA for lymphoma candidate

28 November 2017
2019_biotech_test_vial_discovery_big

Shares of Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) moved up more than 2% to 2,086 yen today, after the company announced that the US Food and Drug Administration had agreed to review the company CTCL candidate under priority status.

The FDA has accepted for review the Biologics License Application (BLA) for mogamulizumab to treat Cutaneous T-cell Lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and has granted Priority Review status.

This BLA is supported by the data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study, the largest global randomized clinical trial of systemic therapy in CTCL.

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

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology