Jan 2022: Pembrolizumab (Keytruda, Merck) igunyazwe i-Food and Drug Administration yokwelapha i-adjuvant yeziguli ezine-renal cell carcinoma (RCC) ezisengozini ephakathi nendawo ephezulu noma ephezulu yokuphinda iphinde ngemva kwe-nephrectomy, noma ngemva kwe-nephrectomy kanye nokukhishwa kabusha kwezilonda ze-metastatic.
Ukusebenza kahle kwahlolwa ezigulini ze-994 ezinengozi ephakathi-phezulu noma ephezulu yokuphindaphinda kwe-RCC, noma i-M1 abukho ubufakazi bokugula, ku-KEYNOTE-564 (NCT03142334), i-multicenter, randomized (1: 1), i-double blind, i-placebo-controlled icala. Iziguli zazinikezwa i-pembrolizumab 200 mg ngomthambo njalo emavikini angu-3 noma i-placebo kuze kube unyaka, noma kuze kube yilapho ukugula kuphindelela noma ubuthi obungabekezeleleki, kuye ngokuthi ikuphi okufike kuqala.
Ukusinda okungenazifo (i-DFS), okuchazwa njengenkathi ephakathi kokuphindaphinda, i-metastasis, noma ukufa, kwakuyisilinganiso esiyinhloko somphumela wokuphumelela. Ukusinda sekukonke bekungenye i-metric yomphumela (OS). Ukuhlaziywa kwesikhashana okucacisiwe kwembula ukuthuthuka okuphawulekayo kwezibalo ku-DFS, ngezenzakalo ezingu-109 (22%) engalweni ye-pembrolizumab kanye nezehlakalo ezingu-151 (30%) engalweni ye-placebo (HR 0.68; 95 amaphesenti CI: 0.53, 0.87; p=0.0010) . Kuzo zombili izingalo, i-DFS emaphakathi yafinyelelwa. Idatha ye-OS yayingaphelele ngesikhathi sokuhlaziywa kwe-DFS, kwathi u-5% wabantu bafa.
Ukungakhululeki kwe-musculoskeletal, ukukhathala, ukuqubuka, isifo sohudo, pruritus, kanye ne-hypothyroidism kwakuyimiphumela emibi evame kakhulu kulokhu kuhlolwa (amaphesenti angama-20).
I-Pembrolizumab inikezwa ngemithamo engu-200 mg njalo emasontweni amathathu noma ama-400 mg njalo emavikini ayisithupha kuze kube yilapho ukugula kuphindelela, ubuthi obungabekezeleleki, noma kufika ezinyangeni eziyi-12.
Click here for full prescribing information for Keytruda.
