FDA给予Incyte的药物以突破性地位, 治疗罕见的血癌、加速发育。
FDA grants breakthrough status to Incyte’s drug for rare blood cancer, speeding development.
食药局授予Incyte实验药物INCA033989 " 突破治疗 " 称号,以治疗一种稀有的基本血栓血病,一种血癌,血小板数很高。
The FDA has granted Breakthrough Therapy designation to Incyte’s experimental drug INCA033989 for a rare form of essential thrombocythemia, a blood cancer marked by high platelet counts.
此举以积极的第一阶段试验结果为基础,旨在加速药物的发展和审查。
The move, based on positive Phase 1 trial results, aims to accelerate the drug’s development and review.
尽管还需要进一步的临床数据和监管批准,但该指定凸显了该疗法在解决一种治疗选择有限的情况方面的潜力。
The designation highlights the therapy’s potential to address a condition with limited treatment options, though further clinical data and regulatory approval are still needed.