Lifileucel ta amince da USFDA don rashin ganowa ko melanoma mai tsauri

Hukumar Abinci da Magunguna ta ba da izini ga gaggawa lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.) on Fabrairu 16, 2024. Wannan yarda ne ga manya marasa lafiya tare da unresectable ko metastatic melanoma wadanda aka riga aka bi da tare da PD-1 blocking antibody. Bugu da ƙari, dole ne majiyyata su zama tabbataccen BRAF V600 kuma sun karɓi mai hana BRAF tare da ko ba tare da mai hana MEK ba.

An gudanar da wani buɗaɗɗen lakabin, gwajin hannu guda ɗaya a duniya a cikin cibiyoyi da ƙungiyoyi masu yawa don tantance aminci da tasiri a cikin marasa lafiya da ba a sake su ba ko metastatic. melanoma. Waɗannan majiyyatan sun karɓi magani kafin magani tare da aƙalla tsarin jiyya guda ɗaya, wanda ya haɗa da PD-1 mai hana ƙwayoyin cuta. Idan sun gwada inganci don maye gurbin BRAF V600, an kuma yi musu magani tare da mai hana BRAF, tare da ko ba tare da mai hana MEK ba. Daga cikin marasa lafiya 89 da aka baiwa lifileucel, biyu an cire su saboda samfurin bai cika ƙayyadaddun bayanai ba kuma biyar an cire su saboda kwatankwacin samfur. An ba Lifileucel bayan tsarin maganin lymphodepleting wanda ya hada da cyclophosphamide a kashi na 60 mg / kg kowace rana tare da mesna na kwanaki 2, sannan fludarabine ya biyo baya a kashi na 25 mg / m2 kowace rana don kwanaki 5. An gudanar da marasa lafiya IL-2 (aldesleukin) a kashi na 600,000 IU / kg kowane 8 zuwa 12 hours har zuwa 6 allurai tsakanin 3 zuwa 24 hours bayan jiko don inganta ci gaban cell a cikin vivo. Matsakaicin matsakaicin adadin lifileucel da aka kawo shine 21.1 × 109 sel masu yiwuwa. Matsakaicin adadin IL-2 (aldesleukin) allurai da aka kawo shine 6.

Ma'aunin inganci na farko shine ƙimar amsa haƙiƙa (ORR) da tsawon lokacin amsawa (DoR). Matsakaicin lokacin amsawar farko ga lifileucel shine watanni 1.5. Nazarin ORR ya haɗa da mahalarta 73 waɗanda aka gudanar da lifileucel a cikin kewayon adadin da aka tsara na 7.5 x109 zuwa 72 × 109 sel masu yiwuwa. Matsakaicin martani na haƙiƙa (ORR) shine 31.5% tare da tazarar amincewa ta 95% (CI) na 21.1% zuwa 43.4%, kuma ba a kai matsakaicin lokacin amsawa (DoR) ba (NR) tare da 95% CI na watanni 4.1 zuwa NR.

Abubuwan da aka rubuta sun haɗa da Gargaɗi na Akwati don mutuwar da ke da alaƙa da jiyya, ci gaba da cytopenia mai tsanani, kamuwa da cuta mai tsanani, matsalolin zuciya, da nakasar koda. Mafi sau da yawa m illa (≥20%) a cikin saukowa tsari na faruwa ne sanyi, pyrexia, gajiya, tachycardia, zawo, febrile neutropenia, edema, rash, hypotension, alopecia, kamuwa da cuta, hypoxia, da dyspnea.

Matsakaicin adadin lifileucel da aka ba da shawarar ya tashi daga 7.5 x 10^9 zuwa 72 x 10^9 sel masu yiwuwa.