相关临床试验
11
2 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2017
进行中（未招募）
2
18.2%
已完成
2
18.2%
招募中
7
63.6%
暂无批准数据
- The FDA has granted fast track designation to birelentinib (DZD8586), a first-in-class noncovalent LYN/BTK dual inhibitor, for treating adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. - Pooled phase I/II study data demonstrated an 84.2% objective response rate in heavily pretreated CLL/SLL patients, with responses observed regardless of BTK resistance mutations including C481X variants. - The dual inhibitor mechanism addresses both BTK-dependent and BTK-independent resistance pathways, representing a potential breakthrough for patients who have failed multiple prior therapies including BTK and BCL-2 inhibitors.
- The FDA is reviewing sunvozertinib for relapsed/refractory NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy. - The application is supported by the phase 2 WU-KONG1 part B study, which showed a 54.3% overall response rate. - Sunvozertinib, an oral single agent, has demonstrated a manageable safety profile, with mostly grade 1 or 2 adverse events. - Sunvozertinib has already been approved in China and was granted breakthrough therapy designation by the FDA in April 2024.
