Agasti 20, i-2021: Muva nje ngoMeyi, i-2021 Lumakras (sotorasib) ivunyelwe yi Ukuphathwa Kwezokudla Nezidakamizwa e-US njengokwelashwa kokuqala kweziguli ezikhulile ezinomdlavuza wamaphaphu ongewona omncane ezithole ukwelashwa okuhleliwe okukodwa kanye nezimila zazo ezinohlobo oluthile lokuguqulwa kofuzo olubizwa nge-KRAS G12C. Lokhu ukwelapha okuhlosiwe kokuqala okugunyazwe izifo ezilimazayo nganoma yikuphi ukuguqulwa kwe-KRAS, okubalela cishe u-25% woshintsho kumdlavuza wamaphaphu wamangqamuzana angewona amancanyana. Kumathumba okungewona amancanyana wamaphaphu, ukuguqulwa kwe-KRAS G12C kufinyelela cishe u-13% wazo zonke izinguquko.
"Sekuyisikhathi eside ukuguqulwa kwezakhi ze-KRAS kuthathwa njengokumelana nokwelashwa kwemithi, okuveza isidingo sangempela seziguli ezinezinhlobo ezithile zomdlavuza," kusho uRichard Pazdur, MD, umqondisi we-FDA's Oncology Center of Excellence kanye nomqondisi obambile we-Office of Oncologic Diseases in Isikhungo se-FDA sokuhlolwa kwezidakamizwa nocwaningo. "Ukwamukelwa kwanamuhla kuyisinyathelo esibalulekile sokuza esikhathini esizayo lapho iziguli eziningi zizoba nendlela yokwelashwa eqondene nomuntu uqobo."
The genetic abnormalities that cause umdlavuza wamaphaphu, the most prevalent cancer type with the greatest fatality rate, can be roughly classified. KRAS is a mutation that affects a collection of genes involved in cell development and division.
In a study of 124 patients with KRAS G12C-mutated umdlavuza wamaphaphu weselula ongewona omncane who had progressed after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy, researchers looked at the efficacy of Lumakras. The objective response rate (the percentage of patients whose tumours are eradicated or decreased) and the duration of response were the two main outcomes assessed. The objective response rate was 36%, with 58 percent of patients reporting a six-month or longer duration of response.
Umthamo we-960 mg uvunyelwe ngokususelwa kubufakazi obutholakalayo bomtholampilo kanye nemodeli ye-pharmacokinetic ne-pharmacodynamic esekela umthamo. Uhulumeni ufuna ukuqulwa kwe-postmarketing njengengxenye yokuhlolwa kwale mvume esheshayo ukubona ukuthi ngabe umthamo ophansi uzoba nomphumela ofanayo wokwelapha.
Uhudo, ubuhlungu bemisipha, isicanucanu, ukukhathala, ukulimala kwesibindi, nokukhwehlela yimiphumela emibi kakhulu yeLumakras. AmaLumakras kufanele agwenywe uma iziguli zikhombisa izimpawu zesifo samaphaphu esiphakathi, futhi kufanele simiswe ngokuphelele uma kutholakala ukuthi isifo. Ngaphambi kokuqala futhi ngenkathi usebenzisa iLumakras, odokotela bezempilo kufanele bahlole izivivinyo zomsebenzi wesibindi sesiguli. ILumakras kufanele ibanjwe, yehliswe umthamo, noma iqedwe ngokuphelele uma isiguli sithola ukulimala kwesibindi. Ngenkathi zithatha i-Lumakras, iziguli kufanele zikugweme ukuthatha imishanguzo yokunciphisa i-asidi, izidakamizwa ezidala noma ezingaphansi kwama-enzyme athile wesibindi, kanye nezidakamizwa ezingama-P-glycoprotein substrates.
ILumakras yamukelwa ngendlela ye-FDA's Accelerated Approval pathway, evumela i-ejensi ukuthi igunyaze imishanguzo yezifo ezibucayi lapho kunesidingo sezempilo esingagcwaliseki futhi ukwelashwa kukhonjisiwe ukuthi kunemiphumela ethile engemihle engabikezela inzuzo yomtholampilo ezigulini. Ucwaningo oluningi luyadingeka ukuqinisekisa nokuchaza izinzuzo zomtholampilo ezingaba khona zikaLumakras.
Lolu hlelo lokusebenza luthole ukubizwa nge-Fast Track, Priority Review, kanye ne-Breakthrough Therapy kusuka ku-FDA.
ILumakras yaphinde yaqokwa njenge-Orphan Drug, enikeza izinkuthazo zezezimali ukusiza nokukhuthaza ukwelashwa kwezinkinga zezifo ezingavamile.
I-Project Orbis, umzamo we-FDA Oncology Center of Excellence, wasetshenziselwa ukwenza lokhu kubuyekezwa. Iphrojekthi Orbis idala indlela yokuthi abalingani bomhlaba wonke bahambise futhi babuyekeze imishanguzo ye-oncology ngasikhathi sinye. I-FDA isebenze neTherapeutic Goods Administration (TGA) yase-Australia, iBrazil Health Regulatory Agency (ANVISA), Health Canada, kanye neMedicine and Healthcare Products Regulatory Agency kulokhu kubukeza (MHRA; United Kingdom). Ezinye izinhlaka ezilawula imithetho zisazibuyekeza izicelo.
I-Amgen Inc. ithole ukugunyazwa kwe-FDA ngeLumakras.
Kanye neLumakras, i-FDA ivume ikhithi ye-QIAGEN therascreen KRAS RGQ PCR kit (evunyelwe yi-QIAGEN GmbH) kanye ne-Guardant360 CDx (eqinisekiswe yi-Guardant Health, Inc.) njenge-diagnostic ye-Lumakras. Ukuhlola ukuthi ngabe i-Lumakras iyindlela efanelekile yokwelapha iziguli, ukuhlolwa kwe-QIAGEN GmbH kuhlaziya izicubu zesimila kanti ukuhlolwa kwe-Guardant Health, Inc. kuhlaziya izibonelo ze-plasma. Uma kungekho kuguquka okutholakala kwisampula le-plasma, isimila sesiguli kufanele sihlolwe.
umthombo: https://www.fda.gov/
Bheka i-athikili ephelele lapha.
