I-carcinoma ye-Pulmonary ne-thyroid: FDA ivuma ukwelashwa ngeRetevmo
IFood and Drug Administration (FDA) igunyaze iRetevmo (selpercatinib) ngezinhlobo ezintathu zokwelashwa komdlavuza eziveza ukuguqulwa (ezishintshayo) kuhlobo lwe-RET (Kuhlelwe kabusha ngesikhathi seTransversal).
I-FDA, igunyaza iRetevmo ekwelashweni kwe-pulmonary carcinoma ye- "cell" engeyona encane
Ikakhulu, iRetevmo ivunyelwe ukwelashwa kwezinhlobo ezahlukene zomdlavuza. Ingahanjiswa ku:
- phazamisa umdlavuza wamaphaphu we-cell non-amancane (NSCLC) kwiziguli zabantu abadala
- umdlavuza we-medullary we-medullary (TCM) noma we-TCM osusabalale, ezigulini ezineminyaka engu-12 noma ngaphezulu
- Phinda ubhekane nomdlavuza we-thyroid osuvele uneminyaka eyi-12 noma ngaphezulu
I-retemvo iyindlela yokuqala yokwelashwa evunyelwe umdlavuza ngokushintshwa kohlobo lwe-RET. Ngokuvunywa kukaRetevmo, i-FDA yancika emiphumeleni yesivivinyo somtholampilo esasifaka iziguli ngalolo nalunye lwezinhlobo ezintathu zomdlavuza.
Ngesikhathi sokuhlolwa kwasemtholampilo, iziguli zathola i-Retevmo 160 mg ngomlomo kabili ngosuku ngosuku kuze kube yilapho izifo ziqhubeka noma ubuthi obungamukeleki. Izinga lokuphendula lilonke (i-ORR), elibonisa iphesenti leziguli ezazinokuthile okuthile kokuqunjelwa kwamathumbu, nesikhathi sokuphendula (i-DOR) zithathwe njengezinyathelo zokugcina eziyimpumelelo.
Ukusebenza kahle ekwelashweni kwe-NSCLC kuhlolwe kuziguli zabantu abadala eziyi-105 ezine-RET-positive fusion NSCLC, phambilini belashwa nge-platinum chemotherapy. I-ORR yeziguli ezingama-105 yayingama-64%.
Ezigulini ezingama-81% ezinempendulo ekwelashweni, ubude bezinyanga okungenani eziyisithupha.
I-FDA kanye nokusebenza kweRetevmo
Ukusebenza kahle kweRetemvo kwahlolwa futhi nasezigulini ezingama-39 ezine-FET-positive fusion NSCLC ezingakaze ziphathwe ngaphambili. Kulezi ziguli, i-ORR yayingama-84%. Ezimweni ezingama-58% zokuphendula ukwelashwa, isikhathi okungenani sasinezinyanga eziyisithupha.
Ukusebenza kahle ekwelashweni kwe-MTC kubantu abadala nasezigulini zezingane kwahlaziywa ezigulini eziyi-143 ezine-RET-mutant TCM esezingeni eliphakeme, eyake yelashwa nge-cabozantinib, vandetanib noma zombili, nasezigulini ezine-RC-mutant TCM esezingeni eliphakeme noma ngaphambili. uthole ukwelashwa nge-cabozantinib noma vandetanib.
I-ORR yeziguli ezingama-55 ezazelashwe ngaphambilini yayingama-69%. Ezigulini ezingama-76% ezinempendulo ekwelashweni, ubude bezinyanga okungenani eziyisithupha.
Ukusebenza kahle kwahlolwa futhi nasezigulini ezingama-88 ezazingalashwa ngaphambilini. I-ORR yalezi ziguli yayingama-73%. Ezimweni ezingama-61% zokuphendula ukwelashwa, isikhathi okungenani sasinezinyanga eziyisithupha.
Ukusebenza kwemithi ku-Food & Drug Administration (FDA)
Ukusebenza kahle kweRetevmo ekwelapheni umdlavuza we-fusion -itive RET kubantu abadala nakwiziguli zezingane ezineminyaka engu-12 nangaphezulu kuhlolwe ocwaningweni olwabhalisa iziguli eziyi-19 ezinomdlavuza we-fusion-positive RET obekuphikisana ne-iodine iodine (RAI), uma ngabe ikhona indlela yokwelashwa efanelekile, futhi ngaphambilini yayithole enye indlela yokwelashwa ehlelekile, kanye neziguli eziyi-8 ezine-FET-positive RET thyroid carcinoma, Refractory ku-RAI kodwa ezazingakaze zithole olunye usizo lokwelashwa.
I-ORR, kweziguli ezingama-19 ezazelashwa ngaphambili, yayingu-79%. Ezimweni ezingama-87% zokuphendula ekwelashweni, isikhathi okungenani sasinezinyanga eziyisithupha. Ezigulini eziyi-8 ezazingalutholi olunye usizo ngaphandle kwe-RAI, i-ORR yayingu-100%.
E-75% yeziguli, impendulo ihlale okungenani izinyanga eziyisithupha. Imiphumela emibi ejwayelekile yeRetevmo kwaba ukwanda kwe-enzymes aspartate aminotransferase (AST) ne-alanine aminotransferase (ALT) esibindini, ukukhuphula ushukela wegazi, ukuncipha kokubala kwamangqamuzana amhlophe egazi, kwehla i-albhamuin egazini, kwehla i-calcium egazini, umlomo owomile, isifo sohudo, i-creatinine ekhuphukayo, i-alkaline phosphatase, umfutho wegazi ophakeme, ukukhathala, ukuvuvukala emzimbeni noma imilenze, ukubalwa kweplatlemle ephansi, ukukhuphuka kwe-cholesterol, ukuqunjelwa, ukuqunjelwa nokuncipha kwe-sodium egazini.
Phakathi kwemiphumela emibi kakhulu ebangelwa yiRetevmo, i-hepatotoxicity, umfutho wegazi ophakeme, ukwelula isikhathi sokuphumula kwe-QT, ukopha kanye nokungezwani komzimba.
URetevmo uthole ukuthathwa kwezidakamizwa zezintandane, ukuBaluleka Kokubaluleka kanye ne-Breakthrough Therapy kwa-FDA futhi sekuvunyelwe ngenqubo yokugijima esheshayo.