相关临床试验
19
12 进行中
药物批准
1
批准总数
监管机构
1
监管机构数
成立时间
2005
进行中（未招募）
11
57.9%
已完成
1
5.3%
尚未招募
1
5.3%
招募中
6
31.6%
- The FDA has granted De Novo Classification Request for OGT's CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic for revumenib (Revuforj) in KMT2A-rearranged acute leukemia. - The diagnostic test rapidly identifies patients eligible for treatment with the first-in-class menin inhibitor revumenib, which was FDA-approved in November 2024 for relapsed/refractory acute leukemia. - More than 95% of patients with KMT2A-rearranged acute leukemia have a KMT2A translocation, making this diagnostic crucial for precision oncology in this high-risk patient population. - The companion diagnostic received Class II device classification rather than the more common Class III, reflecting OGT's extensive experience in hematology diagnostics and regulatory expertise.
- Specialised Therapeutics has expanded its partnership with Incyte to include axatilimab and retifanlimab for distribution in Australia, New Zealand, and Singapore, with potential expansion to other Asia-Pacific countries. - Axatilimab, a first-in-class CSF-1R-blocking antibody approved by the FDA in August 2024, treats chronic graft-versus-host disease after failure of at least two prior systemic therapies. - Retifanlimab, a PD-1 inhibitor, is approved for treating squamous cell carcinoma of the anal canal and Merkel cell carcinoma, with Australia having the highest global incidence of the latter condition. - Both therapies are expected to undergo regulatory and reimbursement approval submissions in the region during 2025.
- The FDA has approved Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes for chronic graft-versus-host disease (GVHD) after two prior systemic therapies. - Niktimvo is the first FDA-approved treatment targeting CSF-1R to reduce inflammation and fibrosis in chronic GVHD, offering a novel approach for patients. - AGAVE-201 trial data showed a 75% response rate at six months with the 0.3 mg/kg dose, demonstrating durable responses across various organs. - Incyte and Syndax anticipate Niktimvo will be available in early February, with patient support programs to ensure access and financial assistance.
- Novel triplet therapies are demonstrating significant positive results in treating relapsed/refractory and newly diagnosed leukemias, according to multiple clinical trials. - A revumenib-based triplet achieved an 82% overall response rate in relapsed/refractory AML patients with KMT2A or NUP98 rearrangements, offering an improved treatment option. - Ivosidenib, venetoclax, and azacitidine triplet showed a 94% overall response rate in IDH1-mutant hematologic malignancies, positioning it as a potential standard-of-care. - Pirtobrutinib, obinutuzumab, and venetoclax triplet yielded high rates of undetectable measurable residual disease in previously untreated CLL patients.
- The FDA has approved revumenib (Revuforj), a first-in-class oral treatment, for acute leukemia in patients one year and older with specific genetic changes. - Revuforj selectively targets the menin protein, which interacts with the KMT2A gene, restoring normal function and halting the growth of leukemic cells. - Clinical trials showed a 21% complete remission rate in patients treated with Revuforj, with remissions lasting about six and a half months. - Syndax, the drug's maker, anticipates Revuforj tablets to be available this month, with a liquid oral solution for smaller patients available soon.
- The FDA has approved Revuforj (revumenib), a menin inhibitor, for relapsed or refractory acute leukemia with KMT2A translocation in adults and pediatric patients. - The approval was based on the AUGMENT-101 trial, which demonstrated strong results in treating patients with this challenging form of leukemia. - Revuforj, developed by Syndax, is the first menin inhibitor to receive FDA approval, marking a significant advancement in leukemia treatment. - Syndax anticipates Revuforj will be available through specialty distributors in November, offering a new treatment option for patients with KMT2A-rearranged acute leukemias.
- The FDA has granted priority review and approval to Syndax Pharmaceuticals' Revuforj (revumenib) for relapsed or refractory acute leukemia with KMT2A translocations. - Revuforj is the first FDA-approved menin inhibitor, marking a significant advancement in treating this aggressive form of leukemia in patients aged one year and older. - Approval was based on the AUGMENT-101 trial, where Revuforj demonstrated a 21% complete remission rate or complete remission with partial hematological recovery. - Syndax plans to launch Revuforj this month, offering a new treatment option for patients with KMT2A-rearranged leukemia who have limited alternatives.
- The FDA has approved Revuforj (revumenib) as the first menin inhibitor for relapsed or refractory acute leukemia with KMT2A translocation in adults and children. - Efficacy was demonstrated in the AUGMENT-101 trial, showing a 21% complete remission rate in patients treated with Revuforj. - Revuforj is expected to be available in the U.S. through specialty distributors in November, with an expanded access program for patients under 40 kg.
- Revumenib shows continued clinically meaningful responses in patients with relapsed/refractory _KMT2Ar_ acute leukemia. - The Phase 2 AUGMENT-101 trial update reveals higher minimal residual disease negativity rates with revumenib. - Treatment with revumenib led to a significant percentage of patients proceeding to hematopoietic stem cell transplant. - The safety profile of revumenib remains manageable, with no discontinuations due to differentiation syndrome or QTc prolongation.
- Syndax Pharmaceuticals announced positive top-line results from the pivotal Phase II portion of the Augment-101 study, evaluating revumenib in acute myeloid leukemia (AML). - The Augment-101 study is designed to assess the safety and efficacy of oral small-molecule revumenib in patients with relapsed or refractory AML. - Despite the positive results, Syndax's shares experienced a significant drop, closing down 26% after the data release, reflecting market caution. - Revumenib is part of the competitive menin-inhibitor space, with these results adding to the growing body of data in this therapeutic area.
