BY: Xiaoyaowan
According to the latest disclosure of the Center for Drug Evaluation, NMPA (CDE) recently, the Class 3 generic drug application of pomalidomide capsules filed by Yangtze River Pharmaceutical has received 2 clinical trial implied permissions, with the indication being adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.
2 Clinical Trial Implied Permissions of Pomalidomide Capsules of Yangtze River Pharmaceutical | ||
Drug name | Acceptance No. | Indication |
Pomalidomide Capsules | CYHS1900621 | Used in combination with dexamethasone to treat adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. |
Pomalidomide Capsules | CYHS1900622 | Used in combination with dexamethasone to treat adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. |
Source: CDE
Blockbuster immunomodulatory agent in the multiple myeloma therapeutic area
Pomalidomide has multiple mechanisms of action in vivo: it can enhance the immunity mediated by T cells and natural killer (NK) cells, regulate the production of various cytokines and also inhibit the hematopoietic tumor cell proliferation.
As a third-generation thalidomide analog, pomalidomide is now used as a small molecule oral immunoregulatory agent and has the antitumor activity, being the immunoregulatory agent with the strongest activity so far.
The original pomalidomide capsules developed by Celgene was approved by the U.S. FDA for marketing in Feb. 2013, with the trade name being Pomalyst and the indication being relapsed and refractory multiple myeloma in adult patients who have received at least 2 prior therapies and have demonstrated disease progression on the last therapy. Celgene's pomalidomide was approved by the EMA for marketing in Europe in Aug. 2013 with the trade name being Imnovid.
Both lenalidomide and thalidomide are classic therapeutic drugs in the multiple myeloma (MM) therapeutic area. Compared to them, pomalidomide can effectively treat MM with a very low dose that has a significant advantage of greatly reducing the adverse drug reaction risk; more importantly, pomalidomide has shown a very good response in MM patients who failed lenalidomide and thalidomide and also a high response rate in MM patients refractory to other new drugs.
Comparison of the Doses of 3 MM Immunoregulatory Agents | |
Drug name | Clinical treatment dose |
Pomalidomide | 4mg |
Lenalidomide | 25mg |
Thalidomide | 800mg |
Source: Public data
Pomalidomide has become the world’s 3rd blockbuster immunoregulatory agent to treat MM following thalidomide and lenalidomide based on the above clinical advantages.
Striking performance
The global sales of Celgene’s pomalidomide exceeded U...
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