News >

FDA Grants BCMA Antibody-Drug Conjugate Breakthrough Status for Myeloma

Jason Harris
Published: Thursday, Nov 02, 2017

Axel Hoos, MD, PhD

Axel Hoos, MD, PhD
The FDA has granted GSK2857916 a breakthrough therapy designation for patients with relapsed/refractory multiple myeloma, according to GlaxoSmithKline (GSK), the manufacturer of the B-cell maturation antigen (BCMA) antibody-drug conjugate.

The EMA and FDA have both designated GSK2857916 as an orphan drug for multiple myeloma.
Cohen AD, Popat R, Trudel S, et al. First in human study with GSK2857916, an antibody drug conjugated to microtubule-disrupting agent directed against b-cell maturation antigen (BCMA) in patients with relapsed/refractory multiple myeloma (MM): Results from study BMA117159 part 1 dose escalation. Blood, 128(22).

... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Oncology Briefings™: Individualizing Treatment After Second-Line Therapy for Patients With mCRCAug 29, 20191.0
Community Practice Connections™: Immunotherapeutic Strategies with the Potential to Transform Treatment for Genitourinary CancersAug 29, 20191.0
Publication Bottom Border
Border Publication