On June 12-13, FDA approved two new indications for K drug, just the day before the K drug was approved for the treatment of cervical cancer. One day later, the US FDA approved pembrolizumab (Keytruda, pembrolizumab) for the treatment of adults and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL) who had relapsed after at least two lines of treatment .
Ansixinta waxay ku saleysneyd xogta 53 bukaan oo leh dib-u-soo-noqosho ama diidmo PMBCL oo ka timid multicenter, sumad furan, hal gacan oo tijaabo ah KEYNOTE-170 (NCT02576990). Bukaanku waxay heleen 200 mg oo ah Pembrolizumab xididada la siiya 3-dii usbuucba 24 ilaa sunta aan la aqbali karin ama horumarka cudurka, ama ilaa 45 bilood bukaanada aan horumarin. Qiyaasta guud ee wax ku oolka ahi waa 11%, oo ay ku jiraan 34% saamaxaad dhammeystiran iyo 9.7% dembi dhaaf qayb ahaan. Intii lagu jiray mudada dabagalka (dhexdhexaadku wuxuu ahaa XNUMX bilood), waqtiga jawaabta dhexdhexaadka lama gaarin. Waqtiga dhexe ee jawaabta ujeeda koowaad waxay ahayd 2.8 bilood. Pembrolizumab laguma talinayo bukaanada qaba PMBCL oo u baahan dhimista burooyinka degdega ah.
KEYNOTE-170, jawaab celinta ugu badan ee bukaanka qaba ≥10% PMBCL waa xanuunka muruqyada, cudurada neef mareenka sare, qandho, daal, qufac, dyspnea, shuban, calool xanuun, lallabbo, arrhythmia iyo madax xanuun. Pembrolizumab waa la joojiyay ama la joojiyay sababo la xiriira falcelinno xun oo ku yimid 8% iyo 15% bukaannada, siday u kala horreeyaan. 25% bukaannadu waxay leeyihiin falcelinno xun oo u baahan daaweynta corticosteroid, iyo 26% bukaannada ayaa leh falcelinno xun.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610670.htm
