Nalu uhlu lwezidakamizwa zakamuva ze-anticancer emakethe.
1) Epacadostat
Epacadostat is undoubtedly a bright star in the IDO field. The results of clinical trials show that the combination of IDO inhibitors and programmed death receptor 1 (PD-1) monoclonal antibody has some advantages over PD-1 alone. anti. Incyte has reached a cooperation agreement with the two giants of PD-1 monoclonal antibody Merck and BMS, and also extensively explored the combined function of Epacadostat and other immune checkpoint inhibitors. The indications also cover multiple cancer categories, but Incyte seems Not content with this, their every move has attracted much attention. Incyte purchased the global development and commercial rights of all indications of Macrogenis’ PD-1 monoclonal antibody drug MGA012 in October to further strengthen its PD-1 pipeline. It is believed that the combination of MGA012 and Epacadostat will soon begin.
2) Rova-T
I-Rova-T ngumuthi olwa namagciwane okhomba iphrotheni le-DLL3 ebusweni bamangqamuzana omdlavuza. Isetshenziselwa ukwelashwa okuhlangene komugqa wesibili kwe- umdlavuza omncane we-cell lung futhi isisesigabeni sokuhlola. U-AbbVie ukholelwa ukuthi iRova-T ihlangene ne-Opdivo noma i-Opdivo + Yervoy izoyenza iphumelele emdlavuzeni omncane wamangqamuzana wamaphaphu, kepha kuzodingeka izivivinyo eziningi zokwelashwa ukufakazela impumelelo yayo.
3) I-ARN-509
Apalutamide (ARN-509) is a new generation of anti-androgen drugs developed for the treatment of prostate cancer. Johnson & Johnson has been quietly advancing the clinical development of apalutamide, and although these data have not been seen, it is also exciting to see it move towards regulatory agencies. With Johnson & Johnson’s strong business development team, this variety is expected to become a blockbuster drug.
4) iPertuzumab
As early as June 2012, Pertuzumab was approved by the FDA. It was used in combination with trastuzumab and docetaxel for metastatic breast cancer without anti-HER2 + therapy or chemotherapy. In September 2013, Pertuzumab was further approved by the FDA. It was used in combination with trastuzumab and chemotherapy for neoadjuvant treatment of HER2 + breast cancer. On December 20, 2017, the FDA approved the combination of Pertuzumab with Trastuzumab and chemotherapy for adjuvant treatment of patients with early-stage HER2 + breast cancer with a higher risk of recurrence. At the same time, the FDA changed Pertuzumab’s previous adjuvant therapy for HER2 + breast cancer from accelerated approval to full approval.
5) I-Opdivo
I-Opdivo ingenye ye-PD-1 mAbs esetshenziswa kakhulu ekwenzeni imitholampilo, futhi yamukelwe yi-FDA ngezinkomba eziyisishiyagalolunye. Isicelo sohlu lwe-Opdivo sokwelashwa kolayini wesibili somdlavuza wamangqamuzana ongewona omncane eChina samukelwa yi-CDE ngoNovemba 2, 2017, futhi safakwa ekubuyekezweni okubekwe phambili yi-CDE ngoDisemba 18 ngezizathu zokuthi “kubalulekile izinzuzo zokwelashwa ngokuqhathaniswa nokwelashwa okukhona ”.
6) Inaliti yeThiopenfigrastin
Umjovo weThiofeigrastin, 19K (HHPG-19K, polyethylene glycol recombinant human granulocyte stimulating factor injection), ungasetshenziswa emtholampilo nge-neutropenia ehambisana ne-chemotherapy ezigulini zesimila. U-19K ufake isicelo sohlu (CXSS1300007) ngaphambi kuka-Mashi 4, 2013. Ngokubona ukuthi yayisemakethe kungekudala, yabanjwa nokuzihlola komtholampilo ngoJulayi 22, 2015. NgoMeyi 18, 2016, uHengrui wakhipha isimemezelo ukuhoxisa isicelo sohlu olungu-19K, futhi wathi kuzoqedelwa imininingwane efanele yocwaningo nentuthuko bese kufakwa isicelo ngokushesha okukhulu. NgoMashi 24, 2017, uHengrui waphinde wafaka isicelo sohlu olungu-19K ngaphansi kwegama lesidakamizwa somjovo we-thiopefilgrastim. Kwake kwavela ku-CDE ngesizathu "sezinzuzo ezisobala zokwelashwa ngokuqhathaniswa nokwelashwa okukhona namaphrojekthi amakhulu". Kuhlelwe ukuthi kufakwe ohlwini lokubuyekezwa kokubekwa phambili. Yize ingafakwanga ekubuyekezweni kokugcina, ukubuyekezwa kobuchwepheshe kwaqedwa ngo-Okthoba 13, 2017, futhi kulindwe ukuqinisekiswa kwendawo. Uma iphumelele, kulindeleke ukuthi ithole imvume ye-CFDA ngo-2018Q2.
7) I-Anlotinib
Anlotinib is a multi-target tyrosine kinase inhibitor, which can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases. It has anti-tumor angiogenesis and inhibits tumor growth. It has obtained major national new drugs Special funding for creation. Anlotinib’s application for the treatment of non-small cell lung cancer was accepted by the CDE on March 16, 2017, and it took a special approval channel. On April 27, 2017, it had “significant treatment advantages compared with existing treatments”. The “major project” reason was included in the priority review by CDE. At present, the technical review of the pharmacology and toxicology and clinical parts has been completed, and the pharmacy part is queued for review. After that, it will enter the on-site inspection and issue a three-in-one report.
8) I-Pirlotinib
Pirlotinib is an EGFR / HER2 small molecule inhibitor, developed for the treatment of HER2 + breast cancer, gastric cancer and NSCLC, and has received special funding from the National Key New Drug Development Program. It is a new drug project that Hengrui has high hopes for. Hengrui submitted to CDE a conditional listing application for pirlotinib for breast cancer. The application was accepted by CDE on August 24, 2017, and it took a special approval channel. On September 26, 2017, it had a “significant clinical value, The “major project” reason was included in the priority review by CDE. At present, the technical review of the clinical part has been completed, and the pharmaceutical and pharmacological and toxicological parts are queued for review. It is expected that the CFDA will be approved in 2018Q2.
9) I-Fruquintinib
I-Fruquintinib iyi-molecule encane ye-VEGFR inhibitor eyakhiwe ngokuzimela yi-Hehuang Medicine. Kuhlelelwe ukuthi kuthuthukiswe ukwelapha umdlavuza we-colorectal, umdlavuza wesisu, kanye ne-NSCLC. Isicelo sika-Fruquintinib sokwelashwa komdlavuza we-colorectal othuthukile samukelwa yi-CDE ngo-June 30, 2017, futhi safakwa ekubuyekezweni okubalulekile kwe-CDE ngo-September 4, 2017 ngezizathu zokuthi “inenani elibalulekile lomtholampilo; amaphrojekthi amakhulu". Njengamanje, ukubuyekezwa kobuchwepheshe kwengxenye ye-pharmacology kanye ne-toxicology sekuqediwe, futhi ikhemisi nemigqa yomtholampilo kusalinde ukubuyekezwa. Kulindeleke ukuthi kuvunywe yi-CFDA ukuze kufakwe kuhlu ngo-2018Q3.
10) Olapalli
ILynparza iyinhlangano yokuqala yokuvimbela iPARP emhlabeni ngokususelwa kunqubo ye-DNA damage response (DDR). Kwavunywa okokuqala yi-FDA ngoDisemba 2014 ukwelashwa komugqa wesine komdlavuza we-ovarian we-BRCA + othuthukile. NgoJulayi 17, kulo nyaka, kwavunywa yi-FDA ukwelashwa kolayini wesibili ezigulini ezinomdlavuza we-epithelial ovarian, umdlavuza wesifo sofuba, kanye nomdlavuza oyinhloko we-peritoneal owabuyela emuva ngemuva kokuphendula kuzidakamizwa ezenziwa nge-platinum. Kuze kube manje, uLynparza uselaphe iziguli ezingaphezu kuka-30,000 ezinomdlavuza osezingeni eliphezulu. Ngo-Okthoba 18, i-Lynparza ka-AstraZeneca / Mercedon yathumela kwi-FDA ukuguqulwa kwezakhi zamakhemikhali ze-chemotherapeutic germline BRCA kanye nesicelo sokumaketha somdlavuza webele se-HER2-metastatic (sNDA) samukelwa yi-FDA futhi satholakala
iziqu zokubukeza kuqala, okusebenzayo Isixuku kulindeleke ukuthi sandise kakhulu.
11) Lenvatinib
I-Lemvatinib iyi-kinase inhibitor ehlosiwe eminingi engavimba uchungechunge lwezici zokulawula ezihlanganisa i-VEGFR1-3, FGFR1-4, PDGFRα, KIT, RET kumaseli wesimila. Ngomhla ziyi-13 kuNhlolanja wezi-2015, yagunyazwa yi-FDA njengokubuyekezwa okubalulekile kanye nesidakamizwa sezintandane ukuze simakethwe njengokwelashwa komdlavuza wegilo wegilo ohlukile onobungozi kakhulu obungavumelani ne-iodine enemisebe. Meyi 13, 2016 wagunyazwa yi-FDA ngokuhlanganiswa ne-Afinitor ukwelapha i-advanced renal cell carcinoma ngokwelashwa kwangaphambilini kwe-anti-VEGF. Ngezinkomba zomdlavuza wesibindi, u-Eisai uthumele isicelo sokumaketha eJapan ngoJuni 2017, wafaka isicelo sokumaketha ku-EMA naku-FDA ngoJulayi 2017, futhi wathumela isicelo sokumaketha ku-CFDA ngoNovemba 3, 2017. Sitholwe ngoDisemba 18, Ukubuyekezwa okubalulekile kwe-CDE ka-2017. I-FDA inikeze isidakamizwa sezintandane i-lenvaltinib yokwelapha i-hepatocellular carcinoma. Yamukele i-sNDA ka-Eisai ngoSepthemba 27, futhi yenza isinqumo sokugunyaza ngokuvumelana nenqubo yokubuyekeza evamile yezinyanga ezingu-10, ezovunyelwa ngaphambi kokuphela kukaJulayi.
12) ICeritinib
Ceritinib is a second-generation anaplastic lymphoma kinase (ALK) inhibitor. It was approved by the FDA on April 29, 2014 for crizotinib for intolerance or disease progression in ALK + non-small cell lung cancer, 2017. May 26 FDA approved first-line treatment for ALK + metastatic non-small cell lung cancer. Novartis’ ceritinib capsule listing application was formally accepted by the CDE on December 11, 2017. It should be included in the priority review later (clinical applications have received priority review). It is expected to be approved by the CFDA in 2018Q4. The above summarizes the latest drugs in the treatment of cancer. The drugs are widely used in lung cancer, gastric cancer, liver cancer, breast cancer, and ovarian cancer.
