Zhitong Finance APP learned that on February 22, the recycled component pharmaceutical (regn.us) announced that the US FDA has accepted its two -specific antigen (BCMA) and CD3s two -specific antibody therapy.LINVOSELTAMABs biological product license application (BLA) is granted priority review qualifications to treat adult patients with recurrence/refractory (R/R) multiple osteoma (MM). Patients are receiving at least three past therapiesLater, disease progress has occurred.The PDUFA date for the application was August 22, 2024.
It is understood that Linvoseltamab is a kind of Specific in which the BCMA on the multiple osteoma cells is expressed in CD3 to promote the activation of T cells and cancer cells.Sexual antibodies.
The submission of this application is based on the results of the key 1/2 clinical trial Linker-MM1.The test results announced in December last year showed that when the median follow -up time was 11 months, the objective relief rate was observed in patients with a dose of 200 mg in patients with a dose of 200 mg in the 1/2 clinical trial (n = 117) patients with a dose of 200 mg.%, 46%reaching a complete relief or better.
As of the latest data deadline, all patients receiving 200 mg treatment have occurred (AE), of which 85%of the patients have experienced levels ≥ 3 adverse events (AE).The most commonly occurred AE for cytokine release syndrome (CRS; 46%).In CRS cases, most (35%) are level 1, 10%are level 2, and 1 case (1%) is level 3 CRS.
