Perusahaan farmasi Jepang Otsuka (Otsuka) nembé nampi warta anu saé dina aspék pangaturan AS, FDA disatujuan sanyawa anti kanker obat anyar Lo 3 bulan sateuacannansurf (trifluridine / tipiracil, FTD / TPI) dianggo pikeun ngubaran pasien kanker kolorektal métastatik refractory (mCRC) anu henteu deui ngaréspon kana terapi sanés (kémoterapi sareng bioterapi).
Lonsurf (kode ngembangkeun TAS-102) mangrupakeun ubar sanyawa antimetabolit anyar, nu diwangun ku anti tumor nucleoside analog FTD (trifluridine) jeung thymidine phosphorylase inhibitor TPI (tipiracil). Di antarana, FTD bisa ngaganti thymine langsung kana DNA ganda-strand salila réplikasi DNA, nu ngabalukarkeun disfungsi DNA jeung interferes jeung sintésis DNA sél kanker; TPI bisa ngahambat timus phosphorylase patali dékomposisi FTD sarta ngurangan degradasi FTD, Ngajaga konsentrasi getih 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 kangker 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.
Sateuacanna, Lonsurf disatujuan ku otoritas pangaturan Jepang dina Maret 2014; di Éropa, Otsuka ngalebetkeun aplikasi daptar pikeun Lonsurf ka Uni Éropa dina Maret taun ayeuna, sareng perusahaan parantos nandatanganan perjanjian sareng réncangna Servier Kanggo perjanjian $ 130 juta, Servier bakal tanggel waler pikeun penjualan komérsial Lonsurf di buana Éropa .
Pasar pangobatan kanker kolorékal global (CRC) bakal ngahontal $ 9.4 milyar dina 2020.
Numutkeun laporan panilitian anu dikaluarkeun ku perusahaan panilitian pasar global GBI Research, pasar pangobatan kanker kolorektal global (CRC) bakal ngajaga pertumbuhan anu alit sareng stabil dina sababaraha taun ka hareup (2014-2020), ngahontal 9.4 milyar dolar AS dina taun 2020 Dina jaman ramalan, tingkat pertumbuhan taunan sanyawa (CAGR) nyaéta 1.8%, sareng nilai pasar tina pasar dina 2013 $ 8.3 milyar.
Laporan éta nunjukkeun yén pertumbuhan ieu utamina bakal lumangsung di dalapan nagara maju utama, kalebet Amérika Serikat, Jepang, Kanada, sareng lima nagara Éropa (Inggris, Perancis, Jerman, Spanyol, sareng Italia). Taun 2013, Amérika Serikat ngagaduhan pangsa pasar pangubaran kanker kolorektal global (CRC), 44.1%, dituturkeun ku Jepang (14.7%) sareng Jerman (11.9%), sareng Spanyol (4.1%) kalayan pasar panghandapna. babagi. Nagara-nagara ieu diperkirakeun tumbuh dina laju anu langkung laun, iwal Jepang, anu bakal tumbuh dina laju anu langkung gancang (CAGR 5%).
Laporan éta nunjukkeun yén salami periode ramalan, ubar Roche blockbuster Avastin (nami umum: bevacizumab, bevacizumab) sareng Merck (Merck KGaA) ubar blockbuster Erbitux (nami generik: cetuximab), Cetuximab) patén-patén di pasar utama kadaluarsana, bakal ngamajukeun ditampa pasar biosimilars béaya rendah, anu bakal ngawatesan pertumbuhan pasar pangobatan kanker koloréktal global. Obat Roche chemotherapeutic Xeloda (Xeloda, nami generik: capecitabine, capecitabine) ubar generik anu didaptarkeun di pasar-pasar utama dipiharep ogé bakal ngawatesan pertumbuhan pasar pangobatan kanker koloréktal global.
Sanajan kitu, analis GBI Saurabh Sharma nunjuk kaluar yén sanajan patén Avastin kadaluwarsa, ubar bakal ngajaga posisi ngarah na di pasar perlakuan kanker colorectal global (CRC) dugi 2020. Saurabh ngajelaskeun yén Avastin ayeuna loba dipaké dina garis kahiji jeung kadua. -perlakuan garis kanker kolorektal, paduli status K-Ras sabar. Sanaos sambetan reséptor faktor pertumbuhan épidermal (EGFR) anu aya hubunganana parantos dipasarkan pikeun pengobatan jinis liar K-Ras. tumor ; Avastin bakal neraskeun ngadominasi pasar na dina pengobatan status liar-K-Ras metastatik sareng status tumor mutan.
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.
Laporan éta ogé nunjukkeun yén salami periode ramalan (2014-2020), sababaraha ubar pipa anyar diperkirakeun badarat di pasar, kalebet antibodi monoklonal Lilly's Cyramza (ramucirumab), boehringer Ingelheim's three angiokinase inhibitor nintedanib, XBiotech The Monoclonal antibody Xilonix perusahaan . Nanging, ubar-ubaran ieu bakal asup kana perawatan anu kadua kalapa sareng perawatan garis kadua sareng kaopat anu henteu saé pangaruhna ageung pikeun pasar. Obat mérek anu ayeuna aya di pasar bakal terasrasakeun dominasi pasar sabab éta kalebetkeun kana pangobatan lini kahiji anu langkung saheulaanan.
