New Milestones in Multiple Myeloma Therapy: Key Drugs Approved in the U.S. and China

　　【Pharmaceutical Network Product Information】Multiple myeloma, as a malignant tumor of the blood system characterized by the abnormal proliferation of clonal plasma cells, has always been a key focus in the medical field. Recently, there have been two significant pieces of good news in the treatment of this disease: one blockbuster new drug each has been approved for marketing in the United States and China, bringing new hope for treatment to a large number of patients.
 

On October 23 local time, GSK announced that the BCMA ADC Belantamab mafodotin has been approved for marketing by the U.S. FDA. The indication is Belantamab mafodotin in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (MM) who have previously received at least two prior therapies, including proteasome inhibitors (PI) and immunomodulatory agents (IMID).
 

Marabalant monoclonal antibody is a BCMA-targeted ADC composed of a humanized anti-BCMA monoclonal antibody and the cytotoxic drug auristatin F, conjugated through a non-cleavable linker. It can eliminate myeloma cells through multiple mechanisms of action. This is also the world's first approved BCMA ADC.
 

Reportedly, the approval of this indication by the FDA was based on data from the pivotal Phase 3 clinical trial DREAMM-7. In the study, patients were randomly assigned in a 1:1 ratio to receive either Blenrep, bortezomib, and dexamethasone or daratumumab, bortezomib, and dexamethasone (DVd). The efficacy evaluable population included 217 patients (108 in one group and 109 in the other), all of whom had received at least two prior treatment regimens, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMID). Analysis showed that the Blenrep combination demonstrated clinically significant benefits over the active control group. The safety and tolerability of the Blenrep combination were generally consistent with the known profiles of each individual drug. Industry research estimates that the sales potential of belantamab mafodotin could reach up to $2.6 billion after gaining approval.
 

Good news has also been reported in the field of multiple myeloma treatment in the Chinese market. On October 20, Qilu Pharmaceutical's injectable carfilzomib (You'anran®) was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory multiple myeloma.
 

Proteasome inhibitors are the cornerstone drugs for the treatment of multiple myeloma. Carfilzomib, as a second-generation proteasome inhibitor, can irreversibly bind to the N-terminal threonine active site of the 20S proteasome (the proteolytic core particle of the 26S proteasome), exhibiting in vitro anti-proliferative and pro-apoptotic activity against solid tumors and hematologic tumor cells. It inhibits proteasome activity in blood and tissues, thereby slowing tumor growth. Compared with first-generation proteasome inhibitors (such as bortezomib), carfilzomib has stronger and more sustained effects, significantly improving patients' overall response rate (ORR) and complete response rate (CR). When used in combination with immunomodulatory agents, the objective response rate (ORR) for relapsed/refractory patients can reach 60%-80%, and it may still be effective for patients resistant to bortezomib.
 

These two significant achievements in the treatment of multiple myeloma from China and the United States not only enrich the therapeutic options for this disease but also provide more personalized treatment choices for patients in different regions, marking a new phase in the treatment of multiple myeloma.
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.