Inkampani yaseJapan eyenza imithi i-Otsuka (Otsuka) isanda kuthola izindaba ezinhle ezicini zokulawula zase-US, i-FDA igunyaze umuthi omusha wokulwa nomdlavuza Lo izinyanga ezi-3 kusengaphambiliI-surf (i-trifluridine / tipiracil, i-FTD / TPI) isetshenziselwa ukwelapha iziguli ezinomdlavuza we-refractory metastatic colorectal (mCRC) ezingasaphenduli kwezinye izindlela zokwelapha (i-chemotherapy ne-biotherapy).
I-Lonsurf (ikhodi yokuthuthukisa i-TAS-102) iyisidakamizwa esisha esiyinhlanganisela ye-antimetabolite, esakhiwe nge-anti-tumor nucleoside analog FTD (trifluridine) kanye ne-thymidine phosphorylase inhibitor TPI (tipiracil). Phakathi kwazo, i-FTD ingakwazi ukufaka esikhundleni se-thymine ngqo ku-DNA kabili-strand ngesikhathi sokuphindaphinda kwe-DNA, okuholela ekungasebenzi kahle kwe-DNA futhi iphazamise ukuhlanganiswa kwe-cell cell DNA; I-TPI ingavimbela i-thymus phosphorylase ehlobene nokubola kwe-FTD futhi inciphise ukuwohloka kwe-FTD, Gcina ukuhlushwa kwegazi kwe-FTD.
Lonsurf’s approval was based on positive data from an international, randomized, double-blind phase III study RECOURSE. The study involved 800 patients with previously treated metastatic umdlavuza colorectal (mCRC). In the study, patients were randomized to receive Lonsurf + best supportive therapy (BSC) or placebo + BSC until the condition deteriorated or the side effects became unbearable. The data showed that the overall survival of the Lonsurf treatment group was significantly longer than that of the placebo group (OS: 7.1 months vs 5.3 months), while progression-free survival was also significantly longer (PFS: 2 months vs 1.7 months) , Reached the primary and secondary endpoints of the study. In terms of safety, the most common side effects of the Lonsurf treatment group include anemia, weakness, extreme fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever.
Phambilini, iLonsurf yamukelwa yiziphathimandla ezilawulayo zaseJapan ngoMashi 2014; eYurophu, u-Otsuka wafaka isicelo sohlu lwe-Lonsurf ku-European Union ngoMashi kulo nyaka, futhi inkampani isayine isivumelwano nozakwabo uServier Esivumelwaneni esingu- $ 130 million, uServier uzobhekana nokuthengiswa kweLonsurf ezwenikazi i-Europe .
Imakethe yokwelashwa yomdlavuza we-colorectal cancer (CRC) izofinyelela ku- $ 9.4 billion ngo-2020.
Ngokombiko wocwaningo okhishwe yinkampani yocwaningo lwemakethe yomhlaba jikelele i-GBI Research, imakethe yokwelashwa yomdlavuza womhlaba (CRC) izogcina ukukhula okuncane nokuzinzile eminyakeni embalwa ezayo (2014-2020), kufinyelela ku-9.4 billion wamadola aseMelika ngonyaka ka-2020 Ku isikhathi sokubikezela, inani lokukhula lonyaka elihlanganisiwe (i-CAGR) lalingu-1.8%, kanti inani lemakethe emakethe ngo-2013 lalingama- $ 8.3 billion.
Lo mbiko waveza ukuthi lokhu kukhula kuzokwenzeka ikakhulukazi emazweni angu-2013 athuthukile, okuhlanganisa i-United States, Japan, Canada, nasemazweni amahlanu aseYurophu (i-United Kingdom, France, Germany, Spain, ne-Italy). Ngo-44.1, i-United States yaba nesabelo esikhulu kunazo zonke emakethe yokwelapha umdlavuza we-colorectal (CRC) emhlabeni wonke, ibalwa ngama-14.7%, ilandelwa yiJapan (11.9%) neJalimane (4.1%), neSpain (5%) enemakethe ephansi kakhulu. ukwabelana. Lawa mazwe kulindeleke ukuthi akhule ngesivinini esiphansi, ngaphandle kwaseJapan, ezokhula ngesivinini esisheshayo (i-CAGR ka-XNUMX%).
Umbiko uveze ukuthi ngesikhathi sesibikezelo, umuthi we-Roche blockbuster Avastin (igama elijwayelekile: bevacizumab, bevacizumab) kanye noMerck (Merck KGaA) blockbuster drug Erbitux (igama elijwayelekile: cetuximab), Cetuximab) amalungelo obunikazi ezimakethe ezinkulu ziphelelwa yisikhathi, azothuthukisa ukwamukelwa kwezimakethe kwama-biosimilars ashibhile, okuzokhawulela ukukhula kwemakethe yokwelashwa komdlavuza onamabala amakhulu emhlabeni. Isidakamizwa i-Roche chemotherapeutic Xeloda (Xeloda, igama elijwayelekile: capecitabine, capecitabine) imishanguzo ejwayelekile ebhalwe ezimakethe ezinkulu kulindeleke ukuthi iphinde ikhawulele ukukhula kwemakethe yokwelashwa komdlavuza ombaxambili emhlabeni.
Kodwa-ke, umhlaziyi we-GBI uSaurabh Sharma wabonisa ukuthi noma ngabe i-patent ye-Avastin iphelelwa yisikhathi, umuthi uzogcina isikhundla sawo esiholayo emakethe yokwelapha umdlavuza we-colorectal (CRC) emhlabeni wonke kuze kube ngu-2020. U-Saurabh wachaza ukuthi i-Avastin okwamanje isetshenziswa kabanzi emugqeni wokuqala nowesibili. -ukwelashwa komugqa womdlavuza we-colorectal, kungakhathaliseki ukuthi isimo se-K-Ras sesiguli. Nakuba ama-epidermal growth factor receptor (EGFR) inhibitors ahlobene amakethwa ukuze alaphe i-K-Ras wild-type. izicubu ; I-Avastin izoqhubeka nokulawula imakethe yayo ekwelapheni isimo sezimila zasendle se-K-Ras kanye nezicubu eziguqukayo.
The report points out that Bayer ‘s new oral anti-cancer drug Stivarga (regorafenib) is expected to be one of the biggest drivers of growth in the global colorectal cancer (CRC) treatment market. This is mainly due to the expected clinical treatment expansion of the drug as a maintenance treatment The drug is used for the first-line treatment of metastatic colorectal cancer (mCRC) that has had liver metastases removed. Stivarga is an oral multi-kinase inhibitor currently listed in major markets such as the US, EU, and Japan. In addition, Japan ‘s Dapeng Pharmaceutical ‘s anticancer drug Lonsurf (TAS-102) was approved for third- and fourth-line treatment in Japan in 2014, and Amgen ‘s monoclonal antibody Vectibix (panitumumab) was also approved by the United States. And EU approved for first-line treatment. The market acceptance of these new drugs will promote the growth of the global therapeutic market.
Umbiko uphinde waveza ukuthi ngesikhathi sesibikezelo (2014-2020), kulindeleke ukuthi imishanguzo emisha yamapayipi ifike emakethe, kubandakanya ne-Lilly's monoclonal antibody Cyramza (ramucirumab), Boehringer Ingelheim's tripi angiokinase inhibitor nintedanib, XBiotech The monoclonal antibody Xilonix . Kodwa-ke, le mithi izongena ekwelashweni komugqa wesibili nakulayini wesithathu nakolayini wokuncintisana futhi ngeke ibe nomthelela omkhulu emakethe yonke. Izidakamizwa ezinophawu okwamanje ezisemakethe zizoqhubeka nokujabulela ukubuswa emakethe njengoba zifakiwe ekwelashweni komugqa wokuqala phambilini futhi okunenzuzo enkulu.
