Hukumar Abinci da Magunguna ta sabunta yarda da amfani da pembrolizumab (Keytruda, Merck) a hade tare da trastuzumab, fluoropyrimidine, da platinum-dauke da chemotherapy don kula da HER2-tabbataccen ciki ko gastroesophageal junction adenocarcinoma wanda ke ci gaba a gida, marasa lafiya, ko metastatic a cikin gida. ba a sami magani a baya ba. Amincewar da aka sake fasalin ta iyakance amfani da wannan alamar ga marasa lafiya masu ciwon ciwace-ciwacen da ke bayyana PD-L1 (CPS ≥ 1) kamar yadda gwajin da FDA ta amince da shi ya gano, yayin da har yanzu yana bin ƙa'idodin amincewar gaggawa.
FDA ta amince da Agilent PD-L1 IHC 22C3 pharmDx a matsayin na'urar bincike na abokin tarayya don gano marasa lafiya tare da ciki ko GEJ adenocarcinoma wanda ciwace-ciwacen daji ke da PD-L1 magana (CPS ≥ 1).
An yi la'akari da tasiri a cikin KEYNOTE-811 (NCT03615326), binciken da aka gudanar a cibiyoyin da yawa, inda marasa lafiya da HER2-tabbatacce a gida ko metastatic ciki ko GEJ. adenocarcinoma wanda ba a yi amfani da tsarin tsarin magani don cututtukan cututtuka ba an ba da izini don karɓar ko dai magani ko placebo a cikin nau'i biyu na makafi. An ba marasa lafiya ba da izini don karɓar ko dai pembrolizumab 200 MG a cikin jini ko wuribo kowane mako 2 tare da trastuzumab da ko dai fluorouracil da cisplatin ko capecitabine da oxaliplatin a cikin rabo na 1: 1.
Maƙasudin ƙarshen tasiri na farko na KEYNOTE-811 sune rayuwa gabaɗaya (OS) da tsira mara ci gaba (PFS). An ba da izinin a ranar 5 ga Mayu, 2021, bayan kimanta ƙididdigar wucin gadi na ƙimar amsa haƙiƙa (ORR) da tsawon lokacin amsawa (DOR). An kimanta ORR da DOR a farkon mahalarta 264 bazuwar a wancan lokacin. Maƙasudin mayar da martani (ORR) shine 74% (95% CI: 66, 82) a cikin pembrolizumab da ƙungiyar chemotherapy da 52% (95% CI: 43, 61) a cikin placebo da ƙungiyar chemotherapy (p-darajar <0.0001) . Tsawon lokacin amsawa shine watanni 10.6 (kewaye: 1.1 zuwa 16.5) da watanni 9.5 (kewaye: 1.4 zuwa 15.4) a cikin ƙungiyoyi daban-daban.
Wani bincike na wucin gadi na gwaji mai cikakken rajista tare da mahalarta 698 ya nuna cewa a cikin wani yanki na marasa lafiya 104 tare da PD-L1 CPS <1, haɗarin haɗari (HR) don rayuwa gabaɗaya (OS) da tsira ba tare da ci gaba ba (PFS) sun kasance 1.41 (PFS). 95% CI 0.90, 2.20) da 1.03 (95% CI 0.65, 1.64) bi da bi.
Bayanan lafiyar marasa lafiya da aka bi da su tare da pembrolizumab da trastuzumab + chemotherapy a cikin KEYNOTE-811 ya kasance daidai da ka'idodin aminci na trastuzumab + chemotherapy kadai ko pembrolizumab monotherapy.
Shawarar da aka ba da shawarar na pembrolizumab shine 200 MG kowane mako 3 ko 400 MG kowane mako 6 har sai cutar ta ci gaba, rashin iya jurewa, ko kuma na tsawon watanni 24. Gudanar da pembrolizumab kafin trastuzumab da chemotherapy idan an ba su a rana ɗaya.
Cancer
Lutetium Lu 177 dotatate an amince da shi ta USFDA don marasa lafiya na yara masu shekaru 12 da haihuwa tare da GEP-NETS
Lutetium Lu 177 dotatate, magani mai ban sha'awa, kwanan nan ya sami izini daga Hukumar Abinci da Magunguna ta Amurka (FDA) ga marasa lafiya na yara, wanda ke nuna gagarumin ci gaba a cikin ilimin cututtukan cututtukan yara. Wannan amincewar tana wakiltar alamar bege ga yara masu fama da ciwace-ciwacen ƙwayoyin cuta na neuroendocrine (NETs), nau'in ciwon daji da ba kasafai ba amma ƙalubale wanda galibi ke tabbatar da juriya ga hanyoyin warkewa na al'ada.
Alysha Mendossa
Bari 11, 2024
