FDA Accepts Supplemental Biologics License Application (sBLA), Assigns Priority Review to Merck’s KEYTRUDA® (pembrolizumab) for Treatment of Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma (PMBCL) - Data for KEYTRUDA in Patients with Relapsed or Refractory PMBCL Show Overall Response Rate of 41 Percent in Difficult-to-Treat Patient Population
December 11, 2017 Merck (MSD), PD-1 inhibitor, Lymphoma
- PD-1阻害薬キートルーダを縦隔原発B細胞リンパ腫(PMBCL)の治療薬とする効能追加申請をFDAが受理。再発・難治性の患者を対象に奏効率(ORR)41%を達成した。