I-Opdivo ifakwe ohlwini e-United States yokwelashwa komdlavuza wamaphaphu. Iziguli eziningi ezinomdlavuza azikwazi ukuya phesheya ukuze zelashwe ngezizathu ezahlukene. Xhumana no-Opdivo ukuthi ungayisebenzisa kanjani futhi uthemba ukuthi uzokwazi ukuthenga umuthi phesheya.
I-US FDA inweba ukugunyazwa kokusetshenziswa kwe-Opdivo ukwelapha umdlavuza wamaphaphu
Richard Pazdur, MD, Director of the Hematology and Oncology Products Division at the FDA ’s Center for Drug Evaluation and Research, said: “When the results of this clinical trial were first available in December 2014, FDA ’s active work with the company facilitated this early submission and review. , “” This approval will provide patients and health care providers with the knowledge that accompanies the survival benefits of Opdivo and will help guide patient care and future umdlavuza wamaphaphu trials. “Priority review
Lezi zithombe ezinhle kakhulu azifaki lonke ulwazi oludingekayo ukuze usebenzise i-OPDIVO ngokuphepha nangempumelelo. Sicela ubheke ku-OPDIVO ukuze uthole ulwazi oluphelele lwencwadi kadokotela.
Umjovo we-OPDIVO (nivolumab) wokusetshenziswa ngomthambo
Ukugunyazwa kokuqala e-United States: 2014
Izinkomba kanye nokusetshenziswa
Izinguquko ezinkulu zakamuva (okubomvu inguqulo entsha)
Izinkomba nokusetshenziswa (1.2) 3/2015
Izexwayiso nezixwayiso (5.1, 5.2, 5.3, 5.4, 5.5, 5.6) 3/2015
Izinkomba kanye nokusetshenziswa
I-OPDIVO iyi-receptor-1 (PD-1) ehlelwe ngumuntu elungele ukuvimba ukwelashwa kwe-antibody kuziguli ezilandelayo:
(1) Treatment of patients with unresectable metastatic melanoma and ipilimumab [ipilimumab] and, for example, BRAF V600 mutation-positive, disease progression after a BRAF inhibitor. (1.1) This indication is approved under accelerated approval based on the isisu response rate and the durability of the response. Continued approval of this indication may depend on verification and the description of clinical benefit in the verification trial. (1.1, 14)
⑵ Use platinum-based chemotherapy or advanced metastatic squamous umdlavuza wamaphaphu weselula ongewona omncane. (1.2)
Umthamo kanye nendlela yokuphatha
I-3 mg / kg inikezwe ngokufakwa emthanjeni imizuzu engama-60 njalo emavikini ama-2. (2.1)
Ukwakheka nokucaciswa
Umjovo: 40 mg / 4 mL kanye nezixazululo ezingu-100 mg / 10 mL ezitsheni ezilahlwayo (3)
Izimo
Izexwayiso nokuqapha
Ukusabela okungekuhle kwe-immune-mediated: Ama-Glucocorticoid anikezwa ngokuya ngobunzima bokusabela. (5.1, 5.2, 5.3, 5.4, 5.6)
⑴ Inyumoniya evikela amasosha omzimba: ayinikezwanga ngokumaphakathi futhi inqanyulwe unomphela ngenxa yenyumoniya enzima noma esongela ukuphila. (5.1)
⑵ Isifo sokuqaqamba kwamasosha omzimba: Unganikezi ukuphela unomphela ku-colitis emaphakathi noma enzima futhi esongela ukuphila. (5.2)
(3) Isifo sokusha kwesibindi kokuzivikela komzimba: ukuqapha izinguquko ekusebenzeni kwesibindi. Ukungalawuleki okumaphakathi kanye nokuqedwa unomphela kwe-transaminase enzima noma esongela ukuphila noma ukuphakama okuphelele kwe-bilirubin. (5.3)
⑷ I-nephritis ye-immune-mediated kanye nokungasebenzi kahle kwezinso: ukuqapha izinguquko ekusebenzeni kwezinso. Ngokwehluleka okusesilinganisweni kanye nokuqedwa unomphela kokwenyuka okukhulu noma okusongela ukuphila kwe-serum creatinine. (5.4)
⑸ I-immune-mediated hypothyroidism kanye ne-hyperthyroidism: qapha izinguquko ekusebenzeni kwegilo. Qala ukushintshwa kwe-hormone yegilo uma kudingeka. (5.5)
⑹ Ubuthi be-fetus ne-fetus: bungabangela ukulimala kwengane. Yeluleka ngezingozi ezingase zibe khona ku-fetus kanye nokusetshenziswa kokuvimbela inzalo okusebenzayo. (5.7, 8.1, 8.3)
Ukusabela okubi
Ukusabela okubi okuvame kakhulu (≥20%) ezigulini ezinemelanoma ukuqubuka. (6.1)
Ukusabela okungekuhle okuvame kakhulu (≥20%) ezigulini ezinomdlavuza wamaphaphu ongewona omncane we-squamous ukukhathala, ukuphefumula kanzima, ubuhlungu bemisipha namathambo, ukuphelelwa ukudla, ukukhwehlela, isicanucanu, nokuqunjelwa.
Isetshenziswa kubantu abakhethekile
⑴ Ukuncelisa ibele: Qeda ukuncelisa.
