Maamulka Cuntada iyo Dawooyinka ee Maraykanka (oo hadda loo yaqaan FDA) ayaa ansixiyay Portrazza (necitumumab) oo ay weheliso gemcitabine iyo cisplatin ee daaweynta kansarka sambabada unugyada unugyada yaryar ee aan-yarayn ee Noofambar 24, 2015, oo noqonaya kii ugu horreeyay ee la oggolaado daawaynta safka kowaad ee bukaanada qaba kansarka sanbabada unug-yar ee kor u kaca.
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. Kansarka sanbabada ee unugyada yar can be further divided into squamous and non-squamous non-small cell lung cancer, which includes lung adenocarcinoma. Squamous non-small cell kansarka sanbabada 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 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 buro metastasis of tumor cells.
Daraasadda badbaadada iyo waxtarka ee Necitumumab ayaa lagu arkay safka koowaad ee xarun-badan, kala sooc lahayn, tijaabo bukaan-socod III SQUIRE, oo ay ku jiraan 1,093 bukaan oo qaba kansarka sanbabada unug-yar oo aan-yarayn. Bukaannada ayaa si aan kala sooc lahayn loo kala qaybiyay laba kooxood waxayna heleen Gemcitabine + cisplatin + Necitumumab ( GP-ga oo lagu daray Necitumumab) iyo gemcitabine + cisplatin therapy oo keliya ( GP-ga oo keliya).
Natiijooyinku waxay soo jeedinayaan in GP-ga oo lagu daray kooxda daawaynta necitumumab ay si weyn u wanaajisay badbaadada guud (HR 0.84; 95% CI: 0.74-0.96; p = 0.01) marka la barbar dhigo GP-ga kemotherabi koox kali ah, iyo wakhtiga badbaadada dhexe ee bukaanadu waa 11.5 bilood (95). % CI: 10.4-12.6), iyo wakhtiga badbaadada ee gemcitabine + cisplatin kooxda laba-daroogadu waxay ahayd 9.9 bilood (95% CI: 8.9-11.1), iyo khatarta dhimashada ayaa hoos loo dhigay 16% ee isku-dhafka saddexda-daroogada. kooxda, iyo dhexdhexaadiyaha labada kooxood ma horumarin Muddada badbaadadu waxay ahaayeen 5.7 vs 5.5 bilood. Si kastaba ha ahaatee, necitumumab waxtar uma laha daaweynta bukaanada qaba kansarka sanbabada unugyada aan-squamous-ka ahayn ee unugyada yaryar.
Dhibaatooyinka ugu badan ee Necitumumab waxaa ka mid ah finan iyo hypomagnesemia, taas oo keenta daciifnimo murqaha, suuxdin, garaaca wadnaha oo aan joogto ahayn, iwm. Wadnaha oo istaaga iyo geeri degdeg ah ayaa laga yaabaa inay sidoo kale dhacdo, sidaas darteed dhakhtarka qoraya wuxuu u baahan yahay inuu fiiro gaar ah siiyo.
Dr. Richard Pazdur, oo madax ka ah Waaxda Hematology iyo Oncology Products ee Xarunta Qiimaynta iyo Cilmi-baadhista ee FDA, ayaa yidhi: "Noocyada kansarka sanbabada aad bay u kala duwan yihiin, markaa doorashada daawadu waxay ku xiran tahay nooca bukaanka. Portrazza la ansixiyay maanta waa kansarka sanbabada unugyada squamous waa doorasho cusub oo bukaanada si ay u dheereeyaan badbaadada. "
Necituumab (magaca ganacsiga: Portrazza) waxaa suuqgeeyay Eli Lilly iyo Shirkadda Maraykanka. Nivolumab (magaca ganacsiga: OPDIVO, oo loo ogolaaday daawaynta kansarka sanbabada unug yar-yar June 22, 2015) ee lagu xusay maqaalka waxaa iska leh Bristol-Myers Squibb, ramucirumab (Magaca ganacsiga: Cyramza, oo loo ogolaaday daawaynta squamous Kansarka sambabada unugyada aan yareyn Abriil 21, 2014) Sidoo kale waa wax soo saarka Eli Lilly ee Mareykanka. Saddexdan daawo dalka kuma jiraan.
