I-US Food and Drug Administration (ngemuva kwalokhu ebizwa ngokuthi i-FDA) igunyaze i-Portrazza (necitumumab) ihlanganiswe ne-gemcitabine kanye ne-cisplatin ekwelapheni umdlavuza wamaphaphu osezingeni eliphezulu (ometastatic) ongewona omncane ngoNovemba 24, 2015, waba owokuqala Ovunyelwe Ukwelashwa komugqa wokuqala kweziguli ezinomdlavuza wamaphaphu we-squamous ongewona omncane wamaseli.
Lung cancer is currently the malignant tumor with the highest morbidity and mortality, with more than 1 million deaths due to lung cancer worldwide each year. According to clinical and histopathological characteristics, lung cancer can be roughly divided into two types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which non-small cell lung cancer accounts for about 85% of all lung cancers. Umdlavuza wamaphaphu ongewona omncane can be further divided into squamous and non-squamous non-small cell lung cancer, which includes lung adenocarcinoma. Squamous non-small cell umdlavuza wamaphaphu accounts for about 30% of all lung cancers. The prognosis of patients is poor, and the 5-year survival rate is less than 5%. The research and treatment of squamous NSCLC lags far behind lung i-adenocarcinoma. One of the important reasons is that there are too few driving gene markers known to help make clinical treatment decisions. The targeted treatment of lung squamous cell carcinoma faces difficulties and challenges . Because of the greater risk of pulmonary hemorrhage, bevacizumab is not recommended for lung squamous cell carcinoma. Due to economic utility considerations, cetuximab is also limited. As of now, its first-line treatment still has huge medical needs.
At present, the first-line treatment plan for the treatment of squamous non-small cell lung cancer at home and abroad is platinum-containing two-drug chemotherapy (studies have confirmed that cisplatin combined with gemcitabine is more effective), and the second-line treatment abroad is docetaxel or docetaxel combined with a new target Xiang, immunotherapy drugs nivolumab and ramucirumab. Among them, nivolumab is the immunotherapy drug OPDIVO (PD-1 inhibitor), and ramucirumab is an anti-vascular endothelial growth factor (VEGF) inhibitor. These targeted drugs are not listed in the country. This time, Portrazza was approved for use in combination with gemcitabine and cisplatin, becoming the first targeted drug approved for first-line treatment of patients with advanced squamous non-small cell lung cancer.
Necitumumab (trade name: Portrazza) is a human recombinant IgG1 monoclonal antibody of EGFR. EGFR (epidermal growth factor receptor) is a multifunctional glycoprotein widely distributed on the cell membrane of various tissues of the human body. It is a tyrosine kinase Type receptor is one of the four members of the HER / ErbB family, and its mutation or overexpression is associated with malignant phenotypes such as malignant proliferation, inhibition of apoptosis, local infiltration, vascularization, and isisu metastasis of tumor cells.
Ucwaningo lokuphepha nokusebenza ngempumelelo kwe-Necitumumab lubonwe ocwaningweni lomtholampilo olunamaphakathi amaningi, olungahleliwe, oluvulekile lwesigaba sesi-III SQUIRE, oluhlanganisa iziguli eziyi-1,093 ezinomdlavuza wamaphaphu we-squamous ongewona omncane omncane. Iziguli zazihlukaniswe ngokungahleliwe zaba amaqembu amabili futhi zithole i-Gemcitabine + cisplatin + Necitumumab (umuthi we-GP ohlangene ne-Necitumumab) kanye ne-gemcitabine + cisplatin therapy yedwa (uhlelo lwe-GP kuphela).
Imiphumela iphakamisa ukuthi i-GP ehlangene neqembu lokwelapha i-necitumumab ithuthukise kakhulu ukusinda okuphelele (HR 0.84; 95% CI: 0.74-0.96; p = 0.01) uma kuqhathaniswa neqembu le-GP chemotherapy kuphela, futhi isikhathi sokusinda esimaphakathi yizinyanga ze-11.5 (95) % CI: 10.4-12.6), futhi isikhathi sokusinda seqembu le-gemcitabine + cisplatin lezidakamizwa ezimbili kwakuyizinyanga ezingu-9.9 (95% CI: 8.9-11.1), kanti ingozi yokufa yancishiswa ngo-16% ekuhlanganiseni kwezidakamizwa ezintathu. iqembu, kanye ne-median yamaqembu amabili ayizange ithuthuke Izikhathi zokusinda zaziyizinyanga ezingu-5.7 vs 5.5. Kodwa-ke, i-necitumumab ayisebenzi ekwelapheni iziguli ezinomdlavuza wamaphaphu we-non-squamous non-small cell lung.
Imiphumela evame kakhulu ye-Necitumumab ihlanganisa ukuqubuka kanye ne-hypomagnesemia, okubangela ubuthakathaka bemisipha, isithuthwane, ukushaya kwenhliziyo okungavamile, njll. Ukuboshwa kwenhliziyo kungazelelwe nokufa kungazelelwe nakho kungase kwenzeke, ngakho udokotela obekayo udinga ukunaka okukhethekile.
UDkt. Richard Pazdur, inhloko yoMnyango Wezokwelapha Nezifo Zomdlavuza eCenter for Drug Evaluation and Research ye-FDA, wathi: “Izinhlobo zomdlavuza wamaphaphu zihluka kakhulu, ngakho ukukhetha ukwelashwa kuxhomeke ohlotsheni lwesiguli. I-Portrazza egunyazwe namuhla i-lung squamous cell carcinoma Indlela entsha yeziguli yokwandisa isikhathi sokuphila. “
I-Necitumumab (igama lokuhweba: Portrazza) imakethwa ngu-Eli Lilly and Company of the United States. I-nivolumab (igama lokuhweba: OPDIVO, egunyazwe ukwelashwa komdlavuza wamaphaphu we-squamous non-small cell wamaphaphu ngoJuni 22, 2015) okukhulunywe ngayo esihlokweni ngekaBristol-Myers Squibb, ramucirumab (Igama lokuhweba: Cyramza, eligunyazwe ukwelashwa kwe-squamous umdlavuza wamaphaphu ongewona omncane ngo-April 21, 2014) Uphinde ube umkhiqizo ka-Eli Lilly wase-United States. Lezi zidakamizwa ezintathu azikho ohlwini lwezwe.
