<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>

因塞特醫療

<p>因塞特醫療獲得了美國食品藥品監督管理局（FDA）對其實驗性治療 INCA033989 的突破性療法認證，該治療針對原發性血小板增多症。此認證旨在加速那些顯示出前景的治療方法的開發，基於一期臨牀試驗數據表明其良好的耐受性和血小板計數的正常化。該治療適用於攜帶 CALR 突變的 1 型和非 1 型患者。因塞特醫療計劃在 2026 年上半年啓動一個針對對現有療法產生耐藥的患者的註冊項目，這標誌着在罕見的骨髓增生性疾病領域的一項戰略舉措</p>

因塞特醫療的候選藥物針對原發性血小板增多症獲得 FDA 突破性療法認定