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Association details:
Biomarker:No biomarker
Cancer:T Cell Non-Hodgkin Lymphoma
Drug:Cejemly (sugemalimab) (PD-L1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

CStone Announces NMPA Approval of Sugemalimab for Patients with Relapsed or Refractory Extranodal NK/T-cell Lymphoma, the First Anti-PD-1/PD-L1 mAb Approved for this Indication

Published date:
10/31/2023
Excerpt:
CStone Pharmaceuticals...announced that the National Medical Products Administration (NMPA) of China has approved the anti-PD-L1 antibody sugemalimab (Cejemly) for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL). Sugemalimab becomes the world’s first anti-PD-1/PD-L1 monoclonal antibody approved specifically for R/R ENKTL.
Evidence Level:
Sensitive: B - Late Trials
Title:

CStone announces China’s NMPA has accepted and granted priority review to the supplemental new drug application (sNDA) for sugemalimab in the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL)

Published date:
09/13/2022
Excerpt:
CStone Pharmaceuticals...announced that the National Medical Products Administration (NMPA) of China has accepted and granted priority review to the supplemental new drug application (sNDA) for sugemalimab in the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL).
Evidence Level:
Sensitive: B - Late Trials
Title:

CStone Pharmaceuticals Announced FDA Granted Breakthrough Therapy Designation to Anti-PD-L1 Antibody Sugemalimab for the Treatment of Adult Patients with R/R ENKTL

Published date:
10/22/2020
Excerpt:
CStone Pharmaceuticals...today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD)to anti-PD-L1 antibody sugemalimab for the treatment of adult patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL).
Trial ID: