Seattle submits application to FDA for listing of antibody-linked drug enfortumab vedotin

recently, Seattle Genetics/Astellas jointly announced to theFDA(http://to submit a market application (BLA) for theenfortumab vedotin in the research antibody associationdrug(http:// for patients with topical advanced or metastatic urinal skin cancer who have received chemotherapy for PD-1/L1 inhibitors and platinum drugsRegarding Enfortumab vedotinEnfortumab vedotin obtained FDA-awarded "breakthrough drug" for this indication with the results of the Phase I EV-101 study, Seattle Genetics/Astra sly sought FDA accelerated approval for the first patient clinical data in the critical Phase II EV-201 studyIn addition, a Phase III EV-301 study is under way to support the global registration of Enfortumab vedotinAt the
(http://of the ASCOConference in June, Enfortumab vedotin's EV-201 results were published as a heavy summary, attracting a lot of attention125 patients with urinary skin cancer who received chemotherapy for PD-1/L1 and platinum drugs were given Enfortumab vedotin treatment, with a confirmed ORR of 44% and a response duration of 7.6 months, reaching the primary and secondary endpoints, respectivelyThe median OS is 11.7 months and the median PFS is 5.8 monthsMost patients responded after receiving the first cycle of Enfortumab vedotin treatment, and the response level was independent of the patient's previous treatment regimen: 41% (26/63) of patients who had received three or more treatments in the past, 41% (41/100) for patients with no response to PD1-1/PD-L1, orRR for liver transfer patients with ORR38% (19/50)In terms of safety
the most common treatment-related adverse events in Enfortumab vedotin included fatigue (50%), hair loss (49%), red rash (48%), loss of appetite (44%), taste disorders (40%), and peripheral neuropathy (50%) 　　The most common severe adverse events above level 3 in Enfortumab vedotin include neutthere (8%), anemia (7%), fatigue (6%)