<div id="readability-page-1"><div><p><span>The biopharmaceutical company Incyte announced on Sunday that the US FDA has granted the designation of </span><i><span>breakthrough therapy</span></i><span> to its experimental treatment INCA033989, aimed at certain patients with essential thrombocythemia. This designation, intended to accelerate the development of promising treatments, is based on Phase 1 data showing good tolerability of the product and normalization of platelet counts, with responses enhanced at higher doses, regardless of the type of genetic mutation.</span></p><p><span>The treatment is being developed for patients with CALR mutations type 1 and non-type 1. In H1 2026 Incyte plans to launch a registry program targeting patients resistant or intolerant to at least one existing cytoreductive therapy. This decision follows discussions with health authorities and marks an important step in Incyte's strategy to strengthen its portfolio in rare myeloproliferative diseases.</span></p></div></div>

因塞特医疗

<p>因塞特医疗获得了美国食品药品监督管理局（FDA）对其实验性治疗 INCA033989 的突破性疗法认证，该治疗针对原发性血小板增多症。此认证旨在加速那些显示出前景的治疗方法的开发，基于一期临床试验数据表明其良好的耐受性和血小板计数的正常化。该治疗适用于携带 CALR 突变的 1 型和非 1 型患者。因塞特医疗计划在 2026 年上半年启动一个针对对现有疗法产生耐药的患者的注册项目，这标志着在罕见的骨髓增生性疾病领域的一项战略举措</p>

因塞特医疗的候选药物针对原发性血小板增多症获得 FDA 突破性疗法认定