Ekuqaleni kukaMashi, i-National Medical Products Administration yavuma i-Jaypirca® (pirtobrutinib) yokwelapha iziguli ezindala ezine-chronic lymphocytic leukemia (CLL) noma i-small lymphocytic lymphoma (SLL) ezithole okungenani ukwelashwa okukodwa kwangaphambilini, okuhlanganisa ne-Bruton's tyrosine kinase (BTK) inhibitor.
I-Pirtobrutinib iyi-kinase inhibitor ekhetha kakhulu esebenzisa indlela entsha yokubopha i-non-covalent ukuze yandise inzuzo yokubhekisa indlela ye-BTK ezigulini ze-CLL/SLL ezaziphathwe ngaphambilini nge-covalent BTK inhibitor (ibrutinib, acalabrutinib, noma zanubrutinib). I-Pirtobrutinib yathola imvume evela ku-US FDA ngoJanuwari 2023 njenge-non-covalent (reversible) BTK inhibitor. Ngo-Okthoba 2024, i-pirtobrutinib yavunyelwa eShayina njenge-monotherapy yokwelapha iziguli ezindala ezine-relapse or refractory mantle cell lymphoma (MCL) ezake zathola okungenani izindlela zokwelapha ezimbili zangaphambilini, okuhlanganisa ne-Bruton's tyrosine kinase (BTK) inhibitor.
Ukuvunyelwa kwalesi sibonakaliso esisha kusekelwe emiphumeleni evela ocwaningweni lwamazwe ngamazwe, olunezikhungo eziningi, olungahleliwe, lweSigaba sesi-3 se-BRUIN CLL 321. I-BRUIN CLL 321 iyisilingo sokuqala seSigaba sesi-3 esingahleliwe emhlabeni esenziwa ezigulini ezine-CLL/SLL ezazike zelashwa nge-covalent BTK inhibitor (cBTKi) ngaphambilini. Ucwaningo lubhalise iziguli ezingu-238 futhi lwahlola ukusebenza kahle nokuphepha kwe-pirtobrutinib monotherapy uma kuqhathaniswa nokukhetha komcwaningi i-IdelaR (idelalisib plus rituximab) noma i-BR (bendamustine plus rituximab). Imiphumela ibonise ukuthi i-pirtobrutinib yandisa kakhulu i-median progression free survival (PFS) uma kuqhathaniswa nohlelo lokukhetha lomcwaningi (izinyanga ezingu-14.0 vs izinyanga ezingu-8.7; isilinganiso sengozi [HR] = 0.54). Ngaphezu kwalokho, izinga lokuyekiswa ngenxa yezehlakalo ezimbi ezihlobene nokwelashwa laliphansi nge-pirtobrutinib (5.2% vs 21.1%), okusekela kakhulu ukusebenza kwayo kanye nezinzuzo zokubekezelela ezigulini ezaziphathwe nge-covalent BTK inhibitor ngaphambilini.
Xhumana Nathi Ukuze Uqale Uhambo Lwakho Lwethemba
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Isikhathi sokuthunyelwe: Mashi-12-2026