Servier a yau ya sanar da cewa Hukumar Kula da Abinci da Magunguna ta Amurka (FDA) ta karɓi ƙarin ƙarin Sabbin Drug Application na kamfanin (sNDA) don TIBSOVO® (kwayoyin ivosidenib) azaman yuwuwar jiyya ga marasa lafiya tare da cutar sankarar cutar sankara ta IDH1 da ba ta da magani a baya (AML). An ba sNDA Bita na Farko, wanda ke hanzarta bita kuma yana rage burin lokacin bita daga watanni 10 zuwa watanni 6. Bita na fifiko yawanci ana ba da magunguna waɗanda zasu iya ba da babban ci gaba a jiyya ko kuma suna iya ba da jiyya inda babu isassun magani.
"A kan diddigin amincewar FDA na kwanan nan na TIBSOVO a cikin cholangiocarcinoma, mun gamsu da wannan muhimmin mataki na ci gaba a cikin la'akari da hukumar don fadada alamunta na yanzu don haɗawa da jiyya ga marasa lafiya da IDH1-mutated m myeloid leukemia," in ji David. K. Lee, Babban Jami'in Gudanarwa, Sabis Pharmaceuticals. "Muna farin ciki da kyakkyawan yanayin wannan shirin yayin da muke ci gaba da haɓaka jagorancinmu a fannin ilimin cututtukan daji da kuma isar da ƙarin magunguna masu canza rayuwa ga marasa lafiya masu fama da cutar kansa."
Karɓar sNDA yana goyan bayan sakamako daga binciken AGILE, na duniya, gwaji na Phase 3 a cikin marasa lafiya tare da IDH1-mutated AML da ba a kula da su ba, waɗanda aka gabatar a 2021 American Society of Hematology Annual Meeting and Exposition. Bayanan sun nuna cewa jiyya tare da TIBSOVO a hade tare da azacitidine ya inganta ingantaccen rayuwa na kyauta (EFS) (haɗarin haɗari [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011 1,2). Bugu da ƙari, haɗin TIBSOVO tare da azacitidine ya nuna haɓakar ƙididdiga a cikin rayuwa gaba ɗaya (OS) (HR = 0.44 [95% CI 0.27, 0.73]; 1-gefe P = 0.0005), tare da OS na tsakiya na watanni 24.0.
"TIBSOVO ita ce farkon farfagandar ciwon daji don nuna ingantaccen rayuwa ba tare da kyauta ba da kuma rayuwa gaba ɗaya tare da azacitidine a cikin marasa lafiya tare da IDH1-mutated AML a baya," in ji Susan Pandya, MD, Mataimakin Shugaban Clinical Development and Head of Cancer Metabolism Global. Ci gaban Oncology & Immuno-Oncology, Sabis Pharmaceuticals. "Tare da wannan karbuwar FDA don Bita na Farko, mun kusa ba da wannan zaɓin magani mai mahimmanci ga marasa lafiya a Amurka kuma muna fatan yin hulɗa tare da hukumomin gudanarwa a duniya."
A halin yanzu an yarda da TIBSOVO[*] a cikin Amurka azaman maganin kafeyin don kula da manya tare da IDH1-mutant relapsed ko refractory m myeloid cutar sankarar bargo (AML), kuma ga manya tare da sabon kamuwa da cutar IDH1-mutant AML waɗanda ke da shekaru ≥75 ko waɗanda ke da cututtuka waɗanda ke hana amfani da induction chemotherapy mai tsanani. Kwanan nan, an amince da TIBSOVO a matsayin na farko kuma kawai maganin da aka yi niyya ga marasa lafiya tare da IDH1-mutated cholangiocarcinoma a baya.
A yunƙurin kawo sabbin zaɓuɓɓukan jiyya ga majinyata masu fama da wahalar magance cututtukan daji, Servier ya sanya ilimin oncology fifiko a duniya, kuma ya ware fiye da 50% na bincikensa da kasafin kuɗi na haɓakawa ga binciken cutar kansa. Tare da fiye da kadarorin oncology na 21 a matakai daban-daban na ci gaban asibiti, da kuma ayyukan bincike na 20 da ke gudana, Servier ya himmatu don nemo mafita waɗanda ke magance buƙatun haƙuri a duk faɗin nau'in cutar da kuma nau'ikan ƙari iri-iri.
