Taimakawa magunguna masu kyau suna sauraron sifofin kaiwa
CLL shi ne mafi yawan al'umar cutar sankarar bargo . Kamar sauran cututtukan sankarar jini, CLL yana da mummunan jini da jikokin jini. A cikin CLL, kwayoyin cutar sankarar barkewa suna ginawa a hankali a tsawon lokaci. Mutanen da suka ci gaba da CLL suna da bambancin ra'ayi, amma sau da yawa ana bincikar su kuma suna ci gaba da rayuwa ba tare da wata alama ba, don akalla shekaru kaɗan.
Yawanci shine lamarin jini na yau da kullum yana nuna manyan matakan jini na lymphocyte - kuma ba cutar bayyanar cutar sankarar bargo ba - wanda ke taimaka wa likita kuma ya kai ga ganewar asali.
Iri
Dabbobin CLL dabam dabam suna nuna bambanci. Wasu suna girma da sauri fiye da wasu. Kwayoyin cutar sankarar bargo daga sauri da girma da kuma siffar CLL da sannu-sannu suna kama da daidaito, amma jarrabawar jarrabawar zai iya taimakawa wajen bayyana bambanci tsakanin su. Alal misali, kwayoyin da ke dauke da adadin sunadaran da aka kira ZAP-70 da CD38 ana zaton su yi girma a hankali, a cewar Cibiyar Cancer na Amurka.
A wasu lokuta na CLL, wani ɓangare na chromosome 17 ya ɓata - kuma tare da shi, wata mahimmanci wanda ke sarrafa apoptosis (aka tsara kwayar salula ta jiki) da ake kira p53. An cire kashi 17p a cikin kashi 3 zuwa 10 na mutanen da ba a gurfanar da su ba, amma har zuwa kashi 30 zuwa 50 na mawuyacin hali. A wasu kalmomi, maye gurbin 17p na iya nuna alama game da CLL mafi wuya.
Statistics
A shekara ta 2016, za'a kashe kimanin 4,660 daga cutar a Amurka. Kodayake alamun CLL na iya ɓacewa na tsawon lokaci bayan jiyya na farko, an dauke cutar da rashin lafiya kuma mutane da yawa zasu buƙaci ƙarin magani, saboda dawowar kwayoyin cututtuka.
Amincewa FDA Venclexta
Venclexta (venetoclax) shine maganin farko na nau'in da za a yarda - an tsara shi don taimakawa wajen sake yaduwar kwayar halitta ta hanyar ƙaddamar da ƙwayar BCL-2.
Kamar yadda muka gani a sama, CLL wani cuta ne wanda ba zai iya warkewa ba kuma sake dawowa yana da yawa, tare da kimanin kashi 30 zuwa 50 na mutanen da CLL ya ci gaba da samun ƙarancin 17p, alamar kwayar da ke da alaƙa da cuta mai wuya.
Wannan amincewa ta FDA yana nufin cewa Venclexta aka nuna don maganin marasa lafiya tare da CLL tare da maye gurbin 17p, kamar yadda jarrabawar FDA ta amince, wanda ya karbi akalla daya kafin farfadowa. Wannan yardar ta dogara ne akan binciken da aka samu daga binciken likita mai suna M13-982 wanda ya nuna kashi 80 cikin 100 na Venclexta.
Muhimmanci ga marasa lafiya tare da CLL
"Har zuwa rabin mutanen da suka ci gaba da tafiyar CLL sun ragu da 17p, alama ce ta haifar da cututtuka," in ji Sandra Horning, MD, babban jami'in kiwon lafiya da kuma shugaban Kamfanin Gudanar da Ƙasa na Duniya. "Venclexta ita ce ta farko da aka yarda da ita don magance tsarin halitta wanda ke taimakawa wajen hallaka rayuka, kuma wata hanya ce ta taimaka wa mutanen da aka magance su a baya kuma suna da irin wannan mummunar cutar."
An baiwa Venclexta izinin Wuraren Turawa ta FDA don kula da mutanen da suka biyo baya (koma baya ko raguwa) CLL tare da maye gurbin 17p. An tsara zane-zane na Farfesa don gaggauta cigaba da kuma nazarin magunguna da aka yi nufin magance cututtuka ko cututtuka na rayuwa da kuma taimakawa wajen tabbatar da mutane ta hanyar samun damar shiga ta hanyar FDA a wuri-wuri. An samo Sabuwar Magungunan Drug aikace-aikacen Venclexta da Bincike na Farko, da aka tsara ga magungunan da FDA ta ƙaddara don samun damar samar da ingantacciyar ingantaccen magani, rigakafi ko ganewar asali na cutar.
Bayanin Tsaro
Abubuwan da za su iya haifar da mummunar sakamako tare da Venclexta sun hada da ciwon huhu, ƙananan jinin jini tare da zazzaɓi, zazzabi, rashin ciwo mai mahimmanci wanda zai haifar da ƙananan jini , ƙananan jinin jini da ƙwayar cutar ciwon sukari (TLS). Sakamakon sakamako mafi yawa na Venclexta sun haɗa da ƙananan jini jini, cututtuka, tashin zuciya, ƙananan jinin jini, ƙwayar cutar na numfashi na sama, ƙididdigar ƙwararrun plate da gajiya. An gano lafiyar marasa lafiyar marasa lafiya 240 tare da CLL daga likitoci uku na gwagwarmayar gwagwarmayar gwagwarmaya a cikin kashi 43.8 na marasa lafiya. Yawancin sakamako sune daidai da ƙananan hali, tare da kara yawan ƙin ku daga 1 zuwa 4. Sakamakon mafi girma na kashi 3 ko 4 yana da ƙananan ƙwayoyin jinin jini, ƙananan jinin jini da ƙididdigar ƙwayoyin platelet.
A cewar Pheobe Starr a cikin watan Fabrairun shekarar 2016 na "Amfanin Lafiya ta Amurka da Drug," venetoclax yana da irin wannan maganin rikici wanda ke fama da ciwon sikila na Lysis ya zama babban damuwa a nazarin farko, duk da haka ya jagoranci AbbVie (ɗaya daga cikin magoya bayan binciken) da masu binciken su daidaita tsarin jima'i na venetoclax, farawa magani a 20 mg kowace rana da kuma kara da kashi a hankali a kan makonni hudu zuwa kashi 90 na yau da kullum. TLS tare da sababbin tsarin jimillar kashi 6 cikin 100 a cikin gwaji mai mahimmanci, ba tare da TLS ba.
Shirin ingantaccen amincewa da FDA ya ba da damar amincewa da yanayin magani wanda ya cika da bukatar likita don mummunar yanayin da ya faru a farkon shaidar da ya nuna amfanar asibiti. An nuna wannan alamar ta amince da karfin da aka samu bisa ga yawan karɓa. Ci gaba da amincewar wannan nuni na iya kasancewa akan tabbatarwa da bayanin fasalinsu na asibiti a gwaji na tabbatarwa.
Venclexta da BCL-2
Venclexta wani ƙananan kwayoyin halitta ne wanda aka tsara don ɗaure da kuma hana haɓakar BCL-2, wanda ke taka muhimmiyar rawa a cikin tsarin da ake kira apoptosis, ko kuma aka tsara kwayar mutuwa ta cell - ainihin apoptosis wani jerin lalacewa ne na rayuka. Bcl-2 abu ne mai gina jiki na apoptotic. Ta hanyar hana Bcl-2, Venetoclax, yana da tasiri game da kwayoyin cutar kanjamau - yana haifar da mutuwar kwayar halitta.
BCL-2 ta sami sunansa daga binciken da aka gudanar shekaru da yawa da suka wuce a kan lymphomas B-cell . B-lymphocytes, ko B-sassan, irin nau'in jini ne. Masana kimiyya sun fahimci cewa canje-canje ga chromosomes a cikin kwayoyin B suna haifar da raunin Bcl-2, yana barin sel su tsira da girma kamar ciwon daji. Tun daga wannan lokacin, an gano hannuwan BCL-2 a cikin wasu cututtuka. Bugu da ƙari, CLL, BCL-2 yana cikin ƙwayoyin melanoma, nono, prostate da kuma ciwon huhu.
Kamar yadda muka gani, a sama, BCL-2 an kuma danganta shi da kwayoyin cutar kanjamau da suka hana maganin magani. CLL cewa ana samar da sinadarin gina jiki na BCL-2 tare da tsayayya da wasu kwayoyi. An yi imanin cewa hanawa BCL-2 na iya mayar da tsarin sigina wanda ya gaya wa sassan, ciki har da kwayoyin ciwon daji, don halakar da kansa.
AbbVie da Genentech, memba na Roche Group suna ci gaba da Venclexta. Tare, kamfanonin sunyi aikin bincike tare da Venclexta, wanda aka kimantawa yanzu a gwaje-gwaje na gwaji na III na kulawa da CLL, tare da karatu a wasu magunguna daban-daban.
Cutar Gidawa na CLL
Ana kuma nazarin Venclexta a hade tare da sauran kwayoyi da ake amfani da ita don yaƙin CLL. Venclexta ita ce ta farko da aka yarda da ita don inganta apoptosis ta hanyar dakatar da sinadarin BCL-2 - kuma ita ce sabuwar likita ta Genentech ta shekaru goma da ta gabata.
Ya zuwa yau, FDA ta yarda da wasu sababbin kwayoyi don maganin marasa lafiya tare da CLL, ciki har da mai cin hanci mai suna Ibrutinib (Imbruvica) , mai hana PI3K idelalisib (Zydelig), da kuma CD2 obinutuzumab (Gazyva) .
Saboda Venetoclax yana da nau'ayi daban-daban, yana da damar kasancewa da amfani ƙwarai da haɗin tare da wasu magungunan CLL wadanda ke da matakan haɗin aiki.
Sources:
Cibiyar Cancer na Amurka. Mene ne cutar cutar sankarar cutar Lymphocytic?
AbbVie Inc. Bayaniyar Bayaniyar Bayani.
Genentech, Inc. Genentech ya sanar da bayar da taimakon FDA Venclexta ™ (Venetoclax) Ƙaƙatar Gwaji ga mutanen da ke fama da cutar cutar sankarar Lymphocytic.
> Sharuɗɗan Kasuwancin NCCN a Oncology. Shafin 1.2016.
> Roberts AW, Davids MS, Pagel JM, et al. Targetar BCL2 tare da Venetoclax a Cutar Likadasu ta Lymphocytic Cigaba. N Engl J Med . 2016; 374 (4): 311-22.
> Starr P. Venetoclax Yana nuna Babban Ayyuka a CLL. Amfanin lafiya na Amurka da Drug. 2016; 9 (Sakamakon Takaddama): 21.