Chithandizo Chatsopano cha Advanced Prostate Cancer

KUGWIRITSA KWAULERE | eTurboNews | | eTN
Avatar ya Linda Hohnholz
Written by Linda Hohnholz

Accord BioPharma yalengeza lero, mogwirizana ndi Foresee Pharmaceuticals Co., Ltd., kukhazikitsidwa kwa US kwa CAMCEVI™ (leuprolide) 42mg jakisoni emulsion yochizira khansa ya prostate yapamwamba mwa akulu. Bungwe la US Food and Drug Administration lidavomereza New Drug Application (NDA) ya CAMCEVI kuchokera ku Foresee Pharmaceuticals pa Meyi 25, 2021. Jekeseni wa CAMCEVI™ 42 mg ndiwololedwa ku Accord BioPharma ku US kuti azichita malonda.

"Kukhazikitsidwa kwa US kwa CAMCEVI kumatsimikizira kufunikira kwaukadaulo wa Foresee wochita upainiya wa Stabilized Injectable Formulation (SIF) ndipo ndi gawo lalikulu pakukwaniritsa ntchito yathu yopititsa patsogolo chisamaliro," adatero Dr. Ben Chien, yemwe anayambitsa komanso Wapampando wa Foresee. "Tikudziwa kuti Accord BioPharma ili ndi cholinga chofunikirachi."

CAMCEVI ndiye woyamba jekeseni wosabala wa leuprolide mesylate wa jekeseni wa subcutaneous omwe amabwera mu syringe yodzazidwa kale popanda kusakaniza kofunikira. Pakufufuza kotseguka, ndi dzanja limodzi la akulu akulu 137 omwe adalandira 42mg ya CAMCEVI pa Tsiku 0 ndi Sabata 24, CAMCEVI idapereka kuponderezedwa kosasinthika kwa testosterone kumayendedwe otaya jekeseni woyamba, kuyambira Sabata 4 mpaka Sabata 48.1 CAMCEVI sayenera kugwiritsidwa ntchito Odwala omwe ali ndi hypersensitivity kwa GnRH kapena GnRH analogues chifukwa cha zotheka anaphylactic reactions.1 Zotsatira zoyipa kwambiri (≥10%) zomwe zimachitika panthawi yotsatizana yapakati pa masiku a 336 zinali zotentha, kuthamanga kwa magazi, zochitika za malo a jekeseni, matenda apamwamba a kupuma. , kupweteka kwa minofu ndi mafupa, kutopa, ndi kupweteka m'malekezero.1

"Accord Healthcare yakhala ikupereka mankhwala abwino kwambiri ku US kuyambira koyambirira kwa 2000s. Kudzera mumgwirizanowu ndi Foresee pakukhazikitsa kwa CAMCEVI, tili okondwa kukhazikitsa Accord BioPharma ndi lumo lakuthwa kwambiri pazamankhwala apadera, zomwe zipitilira biology kuti zibweretse mwayi wopeza mankhwala apamwamba kwa odwala ku US, "adatero Binish. Chudgar, Wapampando, Accord Healthcare ndi Accord BioPharma.

"Tekinoloje ya Foresee imatilola kupereka chithandizo cha khansa yapamwamba ya prostate yomwe imakhala yothandiza komanso yabwino kwa asing'anga, ndi syringe yodzaza kale ikupereka kukonzekera kosavuta komwe kumapangitsa kuti akatswiri azachipatala azidziwa bwino," adatero Chrys Kokino, Purezidenti wa US. BioPharma ku Accord BioPharma. "CAMCEVI ndi chitsanzo chofunikira cha filosofi yathu - yopitilira biology - pochita."

Zofunika Zachitetezo: CAMCEVI, monga ma agonists ena a GnRH, imayambitsa kuwonjezereka kwapang'onopang'ono kwa testosterone m'magazi mkati mwa sabata yoyamba ya chithandizo zomwe zingayambitse kuipiraipira kwakanthawi kwazizindikiro. Odwala omwe ali ndi zotupa za metastatic vertebral kapena / kapena kutsekeka kwa mkodzo ayenera kuyang'aniridwa mosamala m'masabata angapo oyamba a chithandizo. Hyperglycemia ndi chiopsezo chowonjezeka cha matenda a shuga zanenedwa mwa amuna omwe amalandila GnRH agonists. Milingo ya glucose m'magazi iyenera kuyang'aniridwa ndikuyendetsedwa molingana ndi zomwe zikuchitika masiku ano. Chiwopsezo chowonjezereka cha infarction ya myocardial, kufa mwadzidzidzi kwa mtima, ndi sitiroko zanenedwa mogwirizana ndi kugwiritsa ntchito GnRH agonists. Odwala ayenera kuyang'anitsitsa matenda a mtima komanso malinga ndi zomwe zikuchitika panopa. Thandizo la Androgen Deprivation limatha kukulitsa nthawi ya QT. Kugwedezeka kwanenedwa kwa odwala omwe amalandila GnRH agonists, monga CAMCEVI. Yang'anirani ma seramu a testosterone kutsatira jekeseni wa CAMCEVI. Kutengera zomwe zapezeka m'maphunziro a nyama komanso momwe zimagwirira ntchito, CAMCEVI imatha kuvulaza mwana wosabadwayo ikaperekedwa kwa amayi apakati. Zoyipa zodziwika bwino (≥10%) pakutsata kwapakatikati kwa masiku 336 zinali kutentha kwambiri, kuthamanga kwa magazi, zomwe zimachitika pamalo a jakisoni, matenda am'mimba, kupweteka kwa minofu ndi mafupa, kutopa, komanso kupweteka m'malekezero.

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Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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