On March 13, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed or refractory Waldenström’s Macroglobulinemia (R/R WM) b(Press release, InnoCare Pharma, MAR 13, 2022, View Source [SID1234610009]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"According to the evaluation of the Independent Review Committee (IRC) and the principal investigators, the treatment of R/R WM patients with orelabrutinib at a dose of 150mg once a day reached the primary end point, showing encouraging efficacy, which is expected to improve with the extension of treatment time," said Professor Daobin Zhou, Director of Hematology Department of Peking Union Medical College Hospital. "Meanwhile, orelabrutinib is well tolerated with safety profile in the treatment of WM patients. The incidence of adverse events, especially off-target related serious adverse events, is significantly lower in the clinical trial."
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, "WM poses a threat to patients’ lives. We are encouraged that NMPA has accepted the supplemental New Drug Application for orelabrutinib in the treatment of R/R WM. This sNDA includes 47 patients from 16 clinical centers in China. We hope that orelabrutinib will bring a novel treatment option to R/R WM patients."
On December 25, 2020, orelabrutinib received approval from 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).
About Waldenström’s Macroglobulinemia
Waldenström’s macroglobulinemia is a relatively slow-growing lymphoma characterized by the invasion of bone marrow by lymphoplasmacytic cells secreting monoclonal immunoglobulin M (IgM). The disease usually affects older adults and is primarily found in the bone marrow, although it may also impact lymph nodes and the spleen.
About Orelabrutinib
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
On Dec. 25 2020, 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). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.
In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies.
Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).
Attributed to its excellent selectivity and clinical safety profiles, orelabrutinib is also evaluated in the global phase II studies for the treatment of Multiple Sclerosis (MS), phase II clinical trials for the treatment of Systemic Lupus Erythematosus (SLE) and Primary Immune Thrombocytopenia (ITP) in China.