Iyo FDA yakabvumidza belumosudil yekurapa kwechirwere chisingaperi-kupokana-neyakagamuchirwa chirwere

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August 2021: Mushure mekundikana kweanopfuura maviri epamberi mitsara ye systemic kurapa, iyo Kudya neDrug Administration yakatenderwa belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), kinase inhibitor, yevakuru uye yevarwere varwere vane makore gumi nemaviri nekure vane chirwere chegraft-versus-host (chisingaperi GVHD).

KD025-213 (NCT03640481), yakasarudzika, yakavhurika-dhivhosi, multicenter yedosi-kuyedza kuyedza umo 65 varwere vane chisingaperi GVHD vaibatwa nebelumosudil 200 mg inoitiswa nemuromo kamwe pazuva, yakashandiswa kuongorora kushanda.

The overall response rate (ORR) through Cycle 7 Day 1 was the primary efficacy end measure, with overall response defined as a full response (CR) or partial response (PR) according to the 2014 NIH Consensus Development Project on Clinical Trials in Chronic Graft-versus-Host Disease guidelines. The ORR was 75% (95 percent CI: 63, 85); 6% of patients had a complete response, and 69 percent had a partial response. The average time it took to get a first answer was 1.8 months (95 percent CI: 1.0, 1.9). The median duration of response for chronic GVHD was 1.9 months, measured from first response through progression, death, or new systemic treatments (95 percent CI: 1.2, 2.9). No mortality or new systemic medication initiation occurred in 62 percent (95 percent CI: 46, 74) of patients who achieved response for at least 12 months after response.

Zvirwere, asthenia, kuda kurutsa, manyoka, dyspnea, chikosoro, edoema, haemorrhage, kurwadziwa mudumbu, musculoskeletal pain, kutemwa nemusoro, phosphate yakaderera, gamma glutamyl transferase yakawedzera, maLymphocyte akaderera, uye hypertension ndiyo yakajairika maitiro (20%), kusanganisira rabhoritari. zvisizvo.

Belumosudil inofanira kutorwa kamwe pazuva, nechikafu, mune muyero we200 mg.

Tora rwechipiri pfungwa pane pfupa rekutsvaira


Tumira Mashoko

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