PBAC iboka rakazvimirira renyanzvi rakagadzwa neHurumende yeAustralia. Nhengo dzinosanganisira vanachiremba, nyanzvi dzehutano, nyanzvi dzezvehupfumi uye vamiriri vevatengi.
Basa ravo nderekukurudzira mishonga mitsva yekunyorwa pachirongwa chemishonga yemabhenefiti (PBS). Hapana mushonga mutsva unogona kunyorwa kunze kwekunge komiti ichiita kurudziro yakanaka. PBAC inosangana katatu pagore, kazhinji Kurume, Chikunguru naMbudzi.
Anouya PBAC musangano agenda:
November 2020
Lymphoma uye CLL kutumira mune inotevera ajenda
Mbudzi 2020 lymphoma/CLL kutumira pane agenda
Submission type | Zita rezvinodhaka uye mubatsiri | Mushonga rudzi uye kushandiswa | Rondedzero yakakumbirwa nemubatsiri & chinangwa |
New rondedzero (kutumira zvishoma) | Ibrutinib | Chronic lymphocytic leukemia (CLL); Small lymphocytic lymphoma (SLL); Mantle cell lymphoma | Kukumbira chiremera Inodiwa rondedzero yeibrutinib piritsi pasi pemamiriro akafanana neiyo yakatonyorwa capsule. |
New rondedzero (kutumira zvishoma) | Mogamulizumab (Kyowa Kirin) | Cutaneous T-cell lymphoma (CTCL) | Kuendesazve kukumbira Chikamu 100 (inoshanda mari yechemotherapy) Chiremera Chinodiwa rondedzero yevarwere vane CTCL yakadzokororwa kana refractory avo vakamborapwa kamwe chete yekutanga systemic therapy. |
PBAC zvakabuda mumusangano
July 2020
Lymphoma uye CLL kutumira & mhedzisiro
Chikunguru 2020 PBAC musangano zvabuda kune lymphoma uye CLL kutumira
Mushonga, mutsigiri, rudzi rwekutumira | Mushonga rudzi kana kushandiswa | Rondedzero yakakumbirwa nemubatsiri / chinangwa chekutumira | PMAC mhinduro |
Venetoclax (AbbVie) Shandura kune runyorwa (kutumira kudiki) | Chirwere lymphocytic leukemia (CLL) | Kutumirazve kukumbira Chiremera Chinodiwa runyorwa, pamwe chete neObinutuzumab, yekurapa mutsara wekutanga wevarwere vane CLL vane mamiriro ezvinhu aripo efludarabine based chemotherapy. | Iyo PBAC yakakurudzira kunyorwa kwevenetoclax pamwe chete neobinutuzumab yekurapa kwekutanga kwevarwere vane CLL vane mamiriro ekugara pamwe uye vasina kukodzera fludarabine based chemo- immunotherapy. |
Acalabrutinib (AstraZeneca) | Chronic lymphocytic leukemia (CLL) kana diki lymphocytic lymphoma (SLL) | Kukumbira Chiremera Chinodiwa rondedzero yekurapwa kwevarwere (kungave se monotherapy kana musanganiswa neobinutuzumab) ine CLL isati yamborapwa kana SLL yaionekwa isina kukodzera kurapwa nepurine analogue. Chikumbiro chechipiri chaive chekushandisa chete muboka revarwere vane 17p kubviswa. | PBAC haina kurudzira kunyorwa kweacalabrutinib, kuti ishandiswe se monotherapy kana pamwe chete neobinutuzumab, yekurapa kwekutanga kwevarwere vane CLL kana SLL vanoonekwa sevasina kukodzera kurapwa nepurine analogue. PBAC yakafunga kuti kuwedzera kwemutengo-kunyatsoshanda reshiyo yakanga yakakwira zvisingagamuchirwe uye isina chokwadi pamutengo wataurwa. |
Mogamulizumab (Kyowa Kirin) | Cutaneous T-cell lymphoma (CTCL) | Kukumbira Chikamu 100 (Inoshanda Mari yeChemotherapy) Chiremera Chinodiwa (Yakanyorwa) rondedzero yevarwere vane CTCL yakadzokororwa kana kuti refractory avo vakamborapwa kamwe chete yekutanga systemic therapy. | Iyo PBAC haina kukurudzira kunyorwa kwe mogamulizumab kurapwa kwevarwere vane CTCL yakadzokororwa kana refractory zvichitevera kamwechete kamwechete kwekutanga systemic kurapwa kwechiitiko ichi. Iyo PBAC yakaona kuti huwandu hwekubatsirika kwe mogamulizumab maererano nekufambira mberi kwekusununguka kusununguka uye kurarama kwese kwaisave nechokwadi. Pamusoro pezvo, PBAC yakafunga kuti kuwedzera kwemitengo-yekuita basa kwakakwirisa zvisingagamuchirwi uye kusingazivikanwe pamutengo waitaurwa, uye kukanganiswa kwemari kwaifungidzirwa kwanga kusingazivikanwe. |
Kurume 2020 PBAC musangano agenda ye lymphoma/CLL & yakamirira yakamirira kuita kubva munaNovember 2019
Zita rezvinodhaka uye mubatsiri | Subtype | Kunyora kwakakumbirwa uye chinangwa | PBAC mhedzisiro |
Ibrutinib (Janssen) | Chronic lymphocytic leukemia (CLL) kana diki lymphocytic lymphoma (SLL) | Kuendesazve kukumbira PBS kudzoserwa kurapwa kweCLL kana SLL nehumbowo hwekubvisa imwe kana kupfuura 17p chromosome. | PBAC yakakurudzira iyo PBS rondedzero ye ibrutinib yekutanga-mutsara kurapwa neCLL/SLL nekudzima 17p -ichiri kumirira kunyorwa, kubva munaNovember 2019 |
Acalabrutinib (AstraZeneca) | Chronic lymphocytic leukemia (CLL) kana diki lymphocytic lymphoma (SLL) | Kukumbira PBS rondedzero yekurapa varwere vane kudzokazve kana refractory CLL kana SLL isina kukodzera kurapwa ne purine analogue. | PBAC yakakurudzira kunyorwa kweacalabrutinib kurapwa kwevarwere vane R/R CLL/SLL mumutsara wechipiri kurapwa - yakamirira kuve PBS yakanyorwa kubva munaKurume 2020 |
Pembrolizumab (MSD) | Primary mediastinal B-cell lymphoma (PMBCL) | Kutumirazve kukumbira PBS runyorwa rwekurapa kwePMBCL yakadzokororwa kana kuramba | PBAC yakakurudzira rondedzero yePBS yepembrolizumab yeR/R PMBCL - wichimirira kuve PBS yakanyorwa kubva munaKurume 2020 |