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| National Food and Drug Administration Approves New Therapy for Multiple Myeloma |
Multiple myeloma is an incurable hematological malignant tumor, and its incidence ranks second in China's hematological tumors
.
Professor Huang Xiaojun, director of the Institute of Hematology, Peking University, pointed out that for patients with multiple myeloma, the recurrence of the disease is inevitable, and the treatment after recurrence is more difficult.
On November 12, the National Medical Products Administration approved the innovative targeted drug daretumab injection (Zhao Ke) developed by Johnson & Johnson, which was used in combination with lenalidomide and dexamethasone or with bortezomib and mefa The combination of Lun and prednisone is used to treat newly diagnosed adult patients with multiple myeloma who are not suitable for autologous stem cell transplantation
.
The approval of the new indication for daratumumab is based on data from an Asia-Pacific Phase III clinical study (OCTANS) and two global phase III clinical studies (ALCYONE and MAIA)
The results of the OCTANS study showed that at a median follow-up of 12.
3 months, daretuzumab was combined with bortezomib, melphalan and prednisone, compared with bortezomib, melphalan and prednisone alone.
More patients achieved very good partial remission or better remission, prolonged the median progression-free survival of patients, and reduced the risk of disease progression or death by 57%
.
The results of the ALCYONE study showed that at a median follow-up of 40 months, darretuzumab combined with bortezomib, melphalan and prednisone compared to bortezomib, melphalan and prednisone alone can be used.
Significantly prolonged the patient’s median progression-free survival and reduced the risk of disease progression or death by 58%
.
The results of the MAIA study showed that at a median follow-up of 47.
9 months, daretrolumab combined with lenalidomide and dexamethasone compared with lenalidomide and dexamethasone alone significantly prolonged the patient’s median Progression-free survival reduces the risk of disease progression or death by 44%
.
Daratumumab is the first fully human monoclonal antibody approved to target CD38 in China.
It has a unique and innovative therapeutic mechanism and can directly bind specifically to CD38, an important immunotherapy target on the surface of myeloma cells.
, Induces the death of myeloma cells through multiple mechanisms to achieve deep and lasting remission
.
In 2019, daratumomab was approved to be marketed in China for the single-agent treatment of adult patients with relapsed and refractory multiple myeloma
Professor Wu Depei,Chairman of the Hematology Branch of the Chinese Medical Association and Executive Deputy Director of the National Clinical Research Center for Hematological Diseases, said: "First-line treatment is an important opportunity
for patients with multiple myeloma to obtain lasting remission .
For new diagnoses that are not suitable for autologous stem cell transplantation.
Committee member
