Roche PD-1 mai hana mai haɗarin cutar kansar hanta ne ya gane ta FDA azaman farrar nasara

Share Wannan Wallafa

A jiya ne kungiyar Roche ta Swiss ta sanar da cewa TECENTRIQ® (atezolizumab) A hade tare da Avastin® (bevacizumab) an amince da su ta Hukumar Abinci da Magunguna ta Amurka (FDA) don samun nasara don jiyya na farko (layi na farko) na ci-gaba ko hanta marasa lafiya masu ciwon daji (HCC).

HCC ita ce mafi mahimmanci na firamare ciwon daji . Wannan ingantaccen maganin ya dogara da sakamakon binciken Phase Ib akan aminci da aikin asibiti na TECENTRIQ haɗe da Avastin.

Dokta Sandra Horning, babban jami'in likita na Roche kuma shugaban ci gaban kayayyakin duniya, ya ce: Hepatocellular carcinoma, a matsayin mummunan ƙwayar cuta, yana da iyakance hanyoyin zaɓuɓɓuka kuma shine babban dalilin mutuwa a duniya. Bayanan farko game da maganin wannan cutar tare da TECENTRIQ da Avastin suna da alamar rahama. Muna fatan yin aiki tare da sashen kiwon lafiya don kawo wannan kyakkyawan shirin maganin ga marasa lafiya da cutar sankarar hanta da wuri-wuri.

Tsarin Magunguna na Bugawa (BTD) da nufin hanzarta haɓakawa da nazarin sababbin magunguna don magance cututtuka masu haɗari ko haɗari na rayuwa don tabbatar da cewa waɗannan magunguna sun sami amincewa da FDA da wuri-wuri don fa'idantar da marasa lafiya. Wannan ba shine kawai BTD na 22 da kamfanin Roche ya samar ba, amma kuma na BTD na 3 da kamfanin TECENTRIQ ya samu.

Kungiyar Roche ta wallafa bayanai daga binciken na Phase Ib na cutar sankarar hanta a taron shekara-shekara na American Society of Clinical Oncology (ASCO) a watan Yunin 2018. Sakamakon binciken ya nuna cewa bayan bin tsakiyar 10.3 watanni, an lura da gafarar a 15 (65%) na 23 marasa lafiya masu kimantawa.

Bayan bin tsaka-tsaki na watanni 10.3, ba a kai ga rayuwa ba tare da ci gaba ba (PFS), tsawon lokacin gafara (DOR), lokacin ci gaban cuta (TTP), da rayuwa gabaɗaya (OS) ba. Daga cikin marasa lafiya masu ƙima (n = 43), 28% (n = 12) sun sami sakamako na 3-4 da suka shafi abubuwan da suka shafi jiyya, kuma ba a lura da abubuwan da ba su da kyau na aji 5.

Roche ya samar da ƙarin bayanai daidai da buƙatun FDA, kuma an ba shi cancantar ci gaban nasara. Bayan samun ingantaccen bayanai daga gwaji na gaba, Roche zai buga sakamakon bincike a taron likita na gaba.

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