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 .
Ukuvunyelwa kwakususelwa kudatha evela ezigulini ezingama-53 ezine-PMBCL ebuyile noma ephikisayo evela kwi-multicenter, ilebula evulekile, isilingo esisodwa sengalo KEYNOTE-170 (NCT02576990). Iziguli zathola ama-200 mg wePembrolizumab ngemithambo yegazi njalo emavikini ama-3 kuze kube nobuthi obungamukeleki noma ukuqhubekela phambili kwezifo, noma kuze kufike ezinyangeni ezingama-24 zeziguli ezingazange ziqhubeke. Izinga eliphelele eliphelele liyi-45%, kufaka phakathi i-11% ephelele yokuxolelwa kanye ne-34% yokuxolelwa okuyingxenye. Ngesikhathi sokulandelela (i-median bekuyizinyanga eziyi-9.7), isikhathi sokuphendula esiphakathi asifinyelelwanga. Isikhathi esiphakathi sempendulo yokuqala yenhloso kwakuyizinyanga eziyi-2.8. I-Pembrolizumab ayinconyelwe iziguli ezine-PMBCL ezidinga ukunciphisa isimila esiphuthumayo.
E-KEYNOTE-170, ukusabela okuphikisayo okuvame kakhulu ezigulini ezine-%10% PMBCL ubuhlungu bemisipha, ukutheleleka okuphezulu okuphefumulayo, umkhuhlane, ukukhathala, ukukhwehlela, i-dyspnea, isifo sohudo, ubuhlungu besisu, isicanucanu, i-arrhythmia nekhanda. I-Pembrolizumab inqanyuliwe noma yamiswa ngenxa yokusabela okungalungile ku-8% naku-15% weziguli, ngokulandelana. Iziguli ezingama-25% zibe nezimpendulo ezingezinhle ezidinga ukwelashwa kwe-systemic corticosteroid, kanti iziguli ezingama-26% zibe nokusabela okubi kakhulu.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610670.htm
