SLAMF7 抗体elotuzumab(Empliciti)について、米・FDAが再発難治性多発性骨髄腫に対するポマリドミド+低用量デキサメタゾンへの併用投与としての適応拡大承認申請を受理【BMS】

U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma


PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The FDA granted the application priority review with an action date of December 27, 2018.

 

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