FDA 批准 Nik..Incyte (Nasdaq:INCY ) 和 Syndax Pharmaceuticals (Nasdaq:SNDX ) 宣布,美国食品药品监督管理局 (FDA) 已批准 9 毫克和 22 毫克瓶装
The FDA has approved axatilimab (Niktimvo) for patients with chronic graft-vs-host disease (cGVHD) after failure of at least 2 prior systemic therapies. The phase 2 AGAVE-201 trial (NCT04710576) serves as the basis of this approval as results demonstrated significant and durable responses wi...
FDA approval of NiktimvoTM (axatilimab-csfr) for the treatment of chronic graft-versus-host disease (GVHD) [media release]. 14 Aug 2024. https://www.incyte.com. US Food & Drug Administration. FDA approves axatilimab-csfr for chronic graft-versus-host disease [media release]. 14 Aug ...
In August 2024,the FDA approved axatilimabfor the treatment of patients with chronic GVHD that experienced failure of at least 2 prior lines of therapy. This approval was supported by data from AGAVE-201.3 Regarding safety, 6.3% of patients in the 0.3-mg/kg cohort had adverse effects (AEs...
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In August 2024, the FDA approved axatilimab for the treatment of adult and pediatric patients weighing at least 40 kg patients with cGVHD following disease progression on at least 2 prior lines of therapy.3 The approval was supported by findings from AGAVE-201. References Kit...
FDA-approved therapies for chronic GVHD In the past 10 years, the drugs ibrutinib, ruxolitinib, belumosudil, and axatilimab were approved by the US Food and Drug Administration (FDA) for cGVHD. Here, we discuss which signaling pathways and cell types are targeted, the... SJ Lee,R ...
Patients in this study were treated prior to axatilimab’s approval from January 1, 2022, to July 4, 2024.1They received the dose of 0.3 mg/kg every 2 weeks, which was the FDA-approved dose. The primary end point of the study was ORR at 24 weeks, measured by NIH Consensus Criteria...
[ed] the response rate, including age—in fact, only 7 patients in the whole study were below the age of 17—and severity [of cGVHD at screening,” Wolff noted. “Most importantly, high response rates were seen in patients who received prior FDA-approved agents, including belumosudil, ...
The panelists discuss a novel agent, axatilimab, presented at ASH [American Society of Hematology] Annual Meeting 2023, believed to be close to approval for treating chronic GVHD. Axatilimab is a monoclonal antibody targeting CSF-1 receptor on activated macrophages, addressing both infection-figh...