Legend Biotech begins rolling BLA for myeloma CAR T therapy

By The Science Advisory Board staff writers

December 21, 2020 -- Cell therapies firm Legend Biotech has begun a rolling submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for a chimeric antigen receptor (CAR) T-cell therapy for adults with myeloma.

The therapy is an investigational B-cell maturation antigen (BCMA)-directed CAR T-cell treatment designed for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted based on promising results from a phase IB/II trial evaluating the therapy's safety and efficacy in patients.

Legend's collaborative partner, Janssen Biotech, submitted the BLA to the FDA, noted Legend. In 2017, Janssen and Legend entered into a global license and collaboration agreement to develop and commercialize cilta-cel.

Under terms of its existing agreement, Legend has achieved a $75 million milestone payment related to the clinical development of cilta-cel and submission of the BLA. The firm will also continue to study the efficacy cilta-cel in the ongoing phase II portion of the open-label, multicenter clinical trial.

Bayer, Atara collaborate on CAR T-cell therapies
Bayer and Atara Biotherapeutics have entered into an agreement to research, develop, manufacture, and license mesothelin-directed chimeric antigen receptor...
Janssen acquires rights to AMD gene therapy
Janssen Pharmaceuticals has acquired rights of Hemera Biosciences' investigational gene therapy, HMR59, a one-time, outpatient, intravitreal injection...
CHMP recommends approval for Janssen's mAb in psoriatic arthritis
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval for the expanded use of guselkumab...
J&J to supply EU with 200M COVID-19 vaccine doses
Johnson & Johnson has received approval from the European Commission to supply 200 million doses of Janssen Pharmaceutical's COVID-19 vaccine...
National Institutes of Health launches 4th phase III COVID-19 vaccine study
A phase III clinical trial evaluating the investigational Janssen COVID-19 vaccine Ad26.COV2.S for the prevention of symptomatic COVID-19 in a single-dose...

Copyright © 2020 scienceboard.net


Conferences
Cell Bio 2022
December 3-7
District of Columbia United States
Connect
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter