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Association details:
Biomarker:No biomarker
Cancer:Mantle Cell Lymphoma
Drug:Inokai (orelabrutinib) (BTK inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

InnoCare Announces Approval of Orelabrutinib in Combination with R-CHOP as First-Line Therapy for Mantle Cell Lymphoma in China

Published date:
02/05/2021
Excerpt:
InnoCare Pharm...a leading biopharmaceutical company, announced today that China National Medical Products Administration (NMPA) has approved the clinical trial of Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib in combination with R-CHOP for previously untreated patients with mantle cell lymphoma (MCL).
Secondary therapy:
R-CHOP
Evidence Level:
Sensitive: A1 - Approval
Title:

InnoCare Announces the Approval of Orelabrutinib in China for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma and Relapsed/Refractory Mantle Cell Lymphoma

Published date:
12/27/2020
Excerpt:
InnoCare Pharma...announced today that its BTK inhibitor orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL).
Evidence Level:
Sensitive: B - Late Trials
Title:

InnoCare Announces Breakthrough Therapy Designation of Orelabrutinib by US FDA for Treatment of R/R MCL

Published date:
06/28/2021
Excerpt:
InnoCare Pharma (HKEX: 09969)...announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL).