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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).

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