预约演示
更新于：2025-01-23
Daratumumab/Hyaluronidase-fihj
达雷妥尤单抗/重组人透明质酸酶PH20
更新于：2025-01-23
概要
基本信息
药物类型 单克隆抗体、酶 |
别名 DARA-SC、daratumumab and hyaluronidase-fihj、Daratumumab Injection (Subcutaneous Injection) + [14] |
作用机制 CD38抑制剂(淋巴细胞分化抗原CD38抑制剂)、透明质酸调节剂、ADCC(抗体依赖的细胞毒作用) |
在研适应症 |
非在研适应症- |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2020-05-01), |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (美国) |
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结构/序列
Sequence Code 136165
当前序列信息引自: *****
Sequence Code 9075449L
当前序列信息引自: *****
Sequence Code 9946743H
当前序列信息引自: *****
关联
14
项与 达雷妥尤单抗/重组人透明质酸酶PH20 相关的临床试验NCT06046287
Phase IIa Study to Evaluate Daratumumab for Polyneuropathy Associated With MGUS
NCT06142396
Pilot Study of Daratumumab in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients with Renal Failure
NCT06398457
A Pilot Study of Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
100 项与 达雷妥尤单抗/重组人透明质酸酶PH20 相关的临床结果
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100 项与 达雷妥尤单抗/重组人透明质酸酶PH20 相关的转化医学
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100 项与 达雷妥尤单抗/重组人透明质酸酶PH20 相关的专利（医药）
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243
项与 达雷妥尤单抗/重组人透明质酸酶PH20 相关的文献（医药）2025-12-31ANNALS OF MEDICINE
Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis
Article
作者: Huang, Xianghua ; Guo, Jinzhou ; Chen, Wencui ; Li, Zhen ; Zhao, Liang ; Ren, Guisheng
BACKGROUND:
In recent years, daratumumab (DARA) has gained widespread use in the treatment of systemic light chain (AL) amyloidosis. In this study, we assessed the efficacy and safety of a DARA treatment strategy based on serum free light chain (sFLC) levels and non-fixed cycles.
METHODS:
The study included 123 patients with Al amyloidosis who received DARA at our center between July 2020 and September 2023. All patients received the standard DARA treatment (16 mg/kg weekly for four weeks) during the first course. Subsequent treatments were adjusted based on sFLC levels and the physician's judgment.
RESULTS:
The results demonstrated an impressive overall hematologic response rate (ORR) of 94.3%, with a hematologic very good partial response (VGPR) and complete response (CR) rate of 84.5%. Median time to best hematologic response was 1 months. Cardiac and renal response rates were 39.3% and 60.3%, respectively. Thirty patients experienced grade 1/2 infusion-related reactions after the first infusion. The rate of grade 3/4 adverse events was 21%. The most common adverse events of grade 3 or 4 were pulmonary infection (6.5%), neutropenia and lymphocytopenia (5.7%), elevated transaminases (1.6%), acute kidney injury (1.6%). After a median follow-up of 13 months (range 1-38), The 1-year OS and PFS estimates were 96.5% and 84.4%, respectively.
CONCLUSION:
These findings indicate that the sFLC levels based and non-fixed cycle DARA strategy is an efficacious and safe treatment strategy in both newly diagnosed and relapsed/refractory AL amyloidosis.
2025-01-01Clinical Lymphoma Myeloma & Leukemia
Clinical Characteristics and Survival Outcomes of Patients With Primary and Secondary Plasma Cell Leukemia According to the 2021 Definition: A Single Center Retrospective Study
Article
作者: Parker, Sarah ; Hillengass, Jens ; Wang, Chong ; Attwood, Kristopher ; Azad, Farhan ; Yu, Han ; Shalaby, Khalid
INTRODUCTION:
Plasma cell leukemia (PCL) is a rare malignancy with poor overall survival (OS). Recently, its diagnostic criteria were revised by lowering the threshold of circulating plasma cells from ≥ 20% to ≥ 5%.
METHODS:
Between 2010 and 2024, patients with primary PCL (pPCL) and secondary PCL (sPCL) were identified at a tertiary center. We retrospectively analyzed baseline characteristics, treatment, and survival in months (m).
RESULTS:
We identified 30 patients with pPCL and 29 patients with sPCL. The median time to sPCL in patients who received Daratumumab (Dara)-containing regimens for multiple myeloma was 46.8m compared with 12.3m in patients who did not (P=0.007). Of the whole cohort, 51.9% received an induction regimen with novel agents without chemotherapy. Of the evaluable patients with pPCL and sPCL, 82.1% (23/28) and 64.7% (11/17) achieved partial response or better respectively. Median progression free survival was significantly worse in patients with sPCL than pPCL (2.2 vs. 38.3 months; HR 0.16; 95% CI (0.07-0.35), P < .001). Median OS was also worse in patients with sPCL compared with pPCL (3.1 months vs. NR [not reached]; HR 0.09; 95%CI 0.04-0.23, P < .001). The median post-SCT survival for patients with pPCL was NR compared with 6.7m for patients with sPCL (HR 0.17; 95% CI (0.03-0.83), P = .03). Dara-refractory status was associated with worse OS (HR 5.63; 95% CI (2.75-11.51), P < .0001).
CONCLUSION:
Outcomes of pPCL are improving but remain dismal for sPCL. We explored the role of novel agents, especially Dara, in the treatment of PCL. More prospective trials are needed to improve its outcomes.
2024-12-19BLOOD
Prognostic impact of cytogenetic abnormalities detected by FISH in AL amyloidosis with daratumumab-based frontline therapy
Article
作者: Milani, Paolo ; Zanwar, Saurabh ; Muchtar, Eli ; Lentzsch, Suzanne ; Patwari, Anannya ; Bhutani, Divaya ; Chen, GuiZhen ; Cowan, Andrew ; Chakraborty, Rajshekhar ; Gertz, Morie A. ; D’Souza, Anita ; Kumar, Shaji ; Palladini, Giovanni ; Dispenzieri, Angela ; Bodanapu, Geethika ; Hegenbart, Ute ; Sanchorawala, Vaishali ; Schönland, Stefan O.
Abstract:
We performed an international retrospective study on 283 patients with light chain (AL) amyloidosis to investigate the prognostic impact of cytogenetic abnormalities by fluorescence in situ hybridization, when treated with frontline daratumumab–based therapy. The cytogenetic subgroups of interest were t(11;14), gain/amp(1q) (hereafter, +1q), hyperdiploidy, deletion(13q), del(17p), and myeloma high-risk (HR) translocations (t[4;14], t[14;16], or t[14;20]). The end points of interest were rate of hematologic complete response (heme-CR), very good partial response (VGPR) or better, and hematologic event-free survival (heme-EFS). The incidence of abnormalities was as follows: t(11;14), 53.4%; deletion (13q), 28.9%; +1q, 22.3%; hyperdiploidy, 19.4%; HR translocations, 6.6%; and deletion(17p), 4.5%. The heme-CR rate by cytogenetic subgroups were as follows: t(11;14) vs no t(11;14), 45.2% vs 41.8% (P=0.597); del(13q) vs no del(13q), 46.8% vs 42.8% (P=0.594); +1q vs no +1q, 30.2% vs 47.9% (P=0.022); hyperdiploidy vs no hyperdiploidy, 39.5% vs 44.9% (P=0.541); HR translocations vs none, 45.5% vs 43.1% (P=0.877); and del(17p) vs no del(17p), 50.0% vs 42.9% (P=0.658), respectively. Similarly, +1q was the only subgroup with a significantly lower VGPR or better rate (64.2% vs 79.0%; P=0.033). At a median follow-up of 19.8 months, the median heme-EFS was 49.6 months (95% CI, 24.7-not reached [NR]), and the 2-year overall survival (OS) was 80.98% (95% CI, 75.6-85.4). The presence of +1q was significantly associated with worse heme-EFS on multivariate analysis (HR 2.06, 95% CI, 1.14-3.71; P=0.017). Notably, there was no adverse prognostic impact of t(11;14) on heme-EFS or OS. In conclusion, +1q is associated with worse outcome in the daratumumab-era. Clinical trials testing novel frontline immunotherapies should be enriched in +1q to further improve outcomes in this subgroup.
178
项与 达雷妥尤单抗/重组人透明质酸酶PH20 相关的新闻（医药）2025-01-06
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2024-12-27
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·摩熵医药
上市批准免疫疗法细胞疗法抗体药物偶联物
100 项与 达雷妥尤单抗/重组人透明质酸酶PH20 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 免疫球蛋白轻链淀粉样变性 | 美国 | 2021-01-15 | |
| 多发性骨髓瘤 | 美国 | 2020-05-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 阴燃多发性骨髓瘤 | 申请上市 | 美国 | 2024-11-08 | |
| 难治性多发性骨髓瘤 | 临床3期 | 美国 | 2017-10-27 | |
| 难治性多发性骨髓瘤 | 临床3期 | 日本 | 2017-10-27 | |
| 难治性多发性骨髓瘤 | 临床3期 | 澳大利亚 | 2017-10-27 | |
| 难治性多发性骨髓瘤 | 临床3期 | 巴西 | 2017-10-27 | |
| 难治性多发性骨髓瘤 | 临床3期 | 加拿大 | 2017-10-27 | |
| 难治性多发性骨髓瘤 | 临床3期 | 捷克 | 2017-10-27 | |
| 难治性多发性骨髓瘤 | 临床3期 | 法国 | 2017-10-27 | |
| 难治性多发性骨髓瘤 | 临床3期 | 希腊 | 2017-10-27 | |
| 难治性多发性骨髓瘤 | 临床3期 | 以色列 | 2017-10-27 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 522 | 獵範夢膚窪襯願糧壓願(積憲齋糧築構遞鬱夢齋) = 廠廠選廠築鑰構襯選鏇 窪繭襯壓夢醖積獵獵鏇 (鹹鹹糧鹹蓋簾繭簾膚範, 35 ~ 47) 更多 | 积极 | 2024-07-30 | |||
Intravenous Daratumumab | 獵範夢膚窪襯願糧壓願(積憲齋糧築構遞鬱夢齋) = 獵蓋範構衊餘襯鬱餘構 窪繭襯壓夢醖積獵獵鏇 (鹹鹹糧鹹蓋簾繭簾膚範, 31 ~ 43) 更多 | ||||||
临床2期 | 88 | Carfilzomib 70 mg/m^2+Dexamethasone 40 mg (Arm A: Carfilzomib+Dexamethasone (Kd)) | 簾構醖範壓糧範醖鬱窪(遞齋鹹顧衊製繭鬱選觸) = 艱製醖膚獵範窪蓋鹽壓 積遞衊觸襯糧餘網鏇鏇 (獵蓋範遞築繭願廠遞製, 淵遞鑰網蓋窪齋鑰憲糧 ~ 製膚遞蓋鏇襯夢膚襯簾) 更多 | - | 2023-12-19 | ||
(Arm B: Dara-SC in Combination With Kd (DKd)) | 簾構醖範壓糧範醖鬱窪(遞齋鹹顧衊製繭鬱選觸) = 襯襯願遞蓋顧鏇衊構廠 積遞衊觸襯糧餘網鏇鏇 (獵蓋範遞築繭願廠遞製, 鏇積鏇餘鹹齋廠範觸鏇 ~ 齋餘廠構鬱衊簾襯醖壓) 更多 | ||||||
N/A | 102 | Arm 1 (Premedication continued) | 構糧製淵願鑰餘襯膚獵(艱鑰窪窪顧夢網選構獵) = 醖鏇願積願衊廠糧壓醖 簾簾糧壓鏇夢憲網構襯 (醖繭簾遞壓構選範鏇鑰 ) | 积极 | 2023-05-31 | ||
Arm 2 (Premedication omitted after fourth dose) | 構糧製淵願鑰餘襯膚獵(艱鑰窪窪顧夢網選構獵) = 築顧製餘膚糧艱餘鏇積 簾簾糧壓鏇夢憲網構襯 (醖繭簾遞壓構選範鏇鑰 ) | ||||||
临床3期 | 522 | (Daratumumab IV) | 齋獵積鹽淵網窪齋簾願(網醖糧衊願窪憲築窪壓) = 願網憲鏇鏇鏇憲顧蓋獵 繭積淵鑰鑰構網顧衊網 (範繭窪憲遞鑰淵觸鹹鬱, 繭鏇願獵齋築窪膚齋鑰 ~ 襯製餘積餘廠構觸觸艱) 更多 | - | 2020-07-27 | ||
(Daratumumab SC) | 齋獵積鹽淵網窪齋簾願(網醖糧衊願窪憲築窪壓) = 蓋鑰觸襯糧壓衊醖襯鹽 繭積淵鑰鑰構網顧衊網 (範繭窪憲遞鑰淵觸鹹鬱, 構襯醖鬱獵簾繭夢蓋製 ~ 醖網顧鏇襯願簾鏇窪鬱) 更多 | ||||||
N/A | 94 | 襯艱範夢憲鹽鏇艱願鏇(餘餘鹹選繭醖築鹹壓糧) = 鹽鹹獵積鬱鏇壓廠顧膚 鬱顧簾選蓋壓夢夢蓋齋 (遞顧繭膚夢築範築齋齋 ) | 积极 | 2020-05-14 | |||
Subsequent therapies | 壓齋觸製窪廠夢窪選築(艱鏇窪鹽選積蓋鹽衊築) = 衊遞憲選蓋蓋醖廠衊蓋 淵襯築築觸簾窪壓網簾 (鏇鏇壓齋獵範遞糧餘願 ) |
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