Namuhla i-sanofi-aventis Canada Inc. (i-Sanofi) imemezele ukugunyazwa kwe-Libtayo® (cemiplimab) yokwelashwa kweziguli ezikhulile ezinomdlavuza womlomo wesibeletho eziye zathuthuka noma ngemva kwalokho kwamakhemikhali asekelwe ku-platinum futhi ezidinga ukwelashwa okwengeziwe kwe-systemic ukwelapha okuphindaphindiwe noma okuguquguqukayo. isifo. Ukugunyazwa kusekelwe ocwaningweni lweSigaba 3 SAMAMANDLA-Isibeletho 1 se-Cemiplimab Kubantu Abadala Abanomdlavuza Womlomo wesibeletho (NCT03257267). Ukuhlolwa, obekuwuhlolo lomtholampilo olukhulu kunawo wonke owake waba khona kumdlavuza womlomo wesibeletho othuthukisiwe, wawuhlanganisa iziguli ezinomdlavuza womlomo wesibeletho ophindaphindayo noma we-metastatic omlando wawo bekuyi-squamous cell carcinoma noma i-adenocarcinoma. Ababambiqhaza bahlelwe ngokungahleliwe ukuze bathole i-cemiplimab noma ukukhetha komseshi kwe-chemotherapy. Isiphetho esiyinhloko socwaningo kwaba ukusinda kukonke.
Mark Surka, Ph.D, Oncology Medical Head, Sanofi Canada: “Nakuba amazinga omdlavuza womlomo wesibeletho eCanada ehla ngokubonga, ngenxa yengxenye enkulu yokusebenza ngempumelelo komgomo we-HPV ekuvimbeleni umdlavuza wangaphambi komlomo wesibeletho ukuthi ungabhiii, iCanada isabona i-1400. abesifazane abatholakala benalesi sifo njalo ngonyaka futhi abadinga izinketho zokwelashwa. Siyaziqhenya ngokuletha i-Libtayo imvume kwabesifazane abatholakala benomdlavuza womlomo wesibeletho ophindaphindekayo noma ometastatic, kanye nabasebenzi bezempilo abelaphayo.”
Inkomba yesine ye-Libtayo kumdlavuza onzima ukwelapha
Ngesimemezelo sanamuhla, i-Libtayo manje isigunyaziwe njengenketho ye-immunotherapy kumdlavuza othuthukile omine:
• Ngo-April 2019, i-Libtayo ibe inketho yokuqala yokwelapha amasosha omzimba e-Canada kubantu abadala abane-metastatic noma indawo ethuthukisiwe ye-cutaneous squamous cell carcinoma (CSCC) abangakhethwanga ukuhlinzwa okwelapha noma ngemisebe yokwelapha.
• Ngo-Okthoba 2021, ukutholakala kwe-Libtayo kwanwetshwa ukuze kufakwe abantu abadala abanomdlavuza wamaphaphu weseli ongewona omncane oveza i-PD-L1 ku-≥ 50% wamaseli wesimila (Tumour Proportion Score [TPS] ≥ 50%), njengoba kunqunywa isimila esiqinisekisiwe. ukuhlolwa, okungenakho ukuphambuka kwe-EGFR, ALK noma i-ROS1 abane-NSCLC ethuthukisiwe yangakini abangewona amakhandidethi okuhlinzwa kabusha noma ukuchemezeka okuqondile, noma i-NSCLC ye-metastatic.
• Futhi ngo-Okthoba ka-2021, i-Libtayo yagunyazwa ukwelashwa kwabantu abadala abane-basal cell carcinoma (BCC) ethuthukisiwe endaweni ngaphambilini ababelashwe nge-hedgehog pathway inhibitor (HHI).