PBAC yog lub koom haum kws tshaj lij ywj pheej uas tau xaiv los ntawm Tsoomfwv Australian. Cov tswv cuab suav nrog kws kho mob, kws kho mob, kws kho mob kev noj qab haus huv thiab cov neeg sawv cev ntawm cov neeg siv khoom.
Lawv lub luag haujlwm yog kom pom zoo cov tshuaj tshiab rau kev teev npe ntawm cov phiaj xwm kev pabcuam tshuaj (PBS). Tsis muaj tshuaj tshiab tuaj yeem sau npe tshwj tsis yog pawg neeg ua haujlwm pom zoo. PBAC ntsib peb zaug hauv ib xyoos, feem ntau yog Lub Peb Hlis, Lub Xya Hli thiab Kaum Ib Hlis.
Lub rooj sib tham PBAC yav tom ntej:
Kaum ib hlis 2020
Lymphoma thiab CLL xa tuaj rau hauv cov txheej txheem tom ntej
Kaum Ib Hlis 2020 lymphoma / CLL xa cov txheej txheem
Kev xa tawm hom | Lub npe tshuaj thiab tus txhawb nqa | Hom tshuaj thiab siv | Sau npe thov los ntawm sponsor & lub hom phiaj |
Cov npe tshiab (kev xa me me) | Ibrutinib | Chronic lymphocytic leukemia (CLL); Me lymphocytic lymphoma (SLL); Mantle cell lymphoma | Txhawm rau thov kev tso cai Yuav tsum tau teev npe ntawm ibrutinib ntsiav tshuaj raws li tib yam li cov tshuaj ntsiav uas twb tau teev tseg lawm. |
Cov npe tshiab (kev xa me me) | Mogamulizumab (Kyowa Kirin) | Cutaneous T-cell lymphoma (CTCL) | Kev xa rov qab mus thov Tshooj 100 (cov nyiaj tau txais txiaj ntsig ntawm kev kho mob) Cov Cai Yuav tsum tau teev npe rau cov neeg mob rov qab los lossis rov ua dua tshiab CTCL uas yav dhau los tau kho nrog tsawg kawg ib qho kev kho mob ua ntej |
PBAC cov kev sib ntsib
Lub Xya hli ntuj 2020
Lymphoma thiab CLL xa tawm & cov txiaj ntsig
Lub Xya hli ntuj 2020 PBAC lub rooj sib tham tau tshwm sim rau lymphoma thiab CLL xa
Tshuaj, kev txhawb nqa, hom kev xa tawm | Hom tshuaj los yog siv | Cov npe thov los ntawm tus txhawb nqa / lub hom phiaj ntawm kev xa | Cov txiaj ntsig PMAC |
Venetoclax (AbbVie) Hloov mus rau daim ntawv teev npe (kev xa me me) | Cov kab mob lymphocytic leukemia ntev (CLL) | Kev xa rov qab los thov ib daim ntawv teev npe yuav tsum tau ua, ua ke nrog Obinutuzumab, rau kev kho thawj kab ntawm cov neeg mob CLL uas muaj kev sib koom ua ke rau fludarabine raws li kws khomob. | PBAC pom zoo kom sau npe ntawm venetoclax ua ke nrog obinutuzumab rau thawj kab kev kho mob ntawm cov neeg mob CLL uas muaj kev sib koom ua ke thiab tsis tsim nyog rau kev kho mob fludarabine raws li tshuaj tiv thaiv kab mob. |
Acalabrutinib (AstraZeneca) | Chronic lymphocytic leukemia (CLL) lossis me lymphocytic lymphoma (SLL) | Txhawm rau thov Cov Cai Yuav Tsum Tau teev npe rau kev kho mob ntawm cov neeg mob (xws li kev kho mob monotherapy lossis ua ke nrog obinutuzumab) nrog CLL lossis SLL yav dhau los suav tias tsis tsim nyog rau kev kho mob nrog purine analogue. Qhov kev thov thib ob tsuas yog siv rau hauv pawg pab pawg ntawm cov neeg mob nrog kev tshem tawm 17p. | PBAC tsis tau pom zoo rau cov npe ntawm acalabrutinib, siv los ua monotherapy lossis ua ke nrog obinutuzumab, rau kev kho thawj kab ntawm cov neeg mob CLL lossis SLL uas suav tias tsis tsim nyog rau kev kho mob nrog purine analogue. Lub PBAC tau txiav txim siab tias qhov kev nce nqi ntawm qhov ua tau zoo yog qhov tsis txaus ntseeg siab thiab tsis paub tseeb ntawm tus nqi tau hais tseg. |
Mogamulizumab (Kyowa Kirin) | Cutaneous T-cell lymphoma (CTCL) | Txhawm rau thov Tshooj 100 (Kev Pab Nyiaj Tau Zoo ntawm Tshuaj Khomob) Txoj Cai Yuav Tsum Tau (Sau) cov npe rau cov neeg mob rov qab los lossis rov ua dua tshiab CTCL uas tau kho yav dhau los nrog tsawg kawg ib qho kev kho mob ua ntej. | PBAC tsis pom zoo rau cov npe ntawm mogamulizumab rau kev kho mob ntawm cov neeg mob rov qab los yog refractory CTCL tom qab tsawg kawg ib qho kev kho mob ua ntej rau tus mob no. PBAC tau txiav txim siab tias qhov txiaj ntsig zoo rau mogamulizumab hais txog kev muaj sia nyob dawb thiab tag nrho cov ciaj sia tsis paub tseeb. Tsis tas li ntawd, PBAC tau txiav txim siab qhov kev nce nqi ntawm kev ua tau zoo yog qhov tsis txaus ntseeg siab thiab tsis paub tseeb ntawm tus nqi tau hais tseg, thiab qhov kwv yees qhov cuam tshuam nyiaj txiag tsis paub tseeb. |
Lub Peb Hlis 2020 PBAC lub rooj sib tham txheej txheem rau lymphoma / CLL & tseem tos rau kev nqis tes ua txij lub Kaum Ib Hlis 2019
Lub npe tshuaj thiab tus txhawb nqa | Subtype | Cov npe thov thiab lub hom phiaj | PBAC qhov tshwm sim |
Ibrutinib (Janssen) | Chronic lymphocytic leukemia (CLL) lossis me lymphocytic lymphoma (SLL) | Kev xa rov qab los thov PBS cov nyiaj them rov qab rau kev kho mob ntawm CLL lossis SLL nrog cov pov thawj ntawm ib lossis ntau dua 17p chromosome deletion | PBAC pom zoo rau PBS cov npe ntawm ibrutinib rau kev kho thawj kab nrog CLL / SLL nrog kev tshem tawm 17p -tseem tos kom tau teev npe, txij lub Kaum Ib Hlis 2019 |
Acalabrutinib (AstraZeneca) | Chronic lymphocytic leukemia (CLL) lossis me lymphocytic lymphoma (SLL) | Txhawm rau thov PBS cov npe rau kev kho mob ntawm cov neeg mob rov qab los lossis refractory CLL lossis SLL tsis haum rau kev kho mob nrog purine analogue | PBAC pom zoo cov npe ntawm acalabrutinib rau kev kho mob ntawm cov neeg mob nrog R / R CLL / SLL hauv kab thib ob kho - tos kom PBS teev txij lub Peb Hlis 2020 |
Pembrolizumab (MSD) | Primary mediastinal B-cell lymphoma (PMBCL) | Kev xa rov qab los thov PBS cov npe rau kev kho mob rov qab los yog refractory PMBCL | PBAC pom zoo rau PBS cov npe ntawm pembrolizumab rau R/R PMBCL - wNws yuav tsum yog PBS teev txij lub Peb Hlis 2020 |