Det japanske farmasøytiske selskapet Otsuka (Otsuka) mottok nylig gode nyheter i amerikanske regulatoriske aspekter, FDA godkjente anti-kreftforbindelse nytt stoff Lo 3 måneder i forveiennsurf (trifluridine / tipiracil, FTD / TPI) is used to treat patients with refractory metastatic colorectal cancer (mCRC) who no longer respond to other therapies (chemotherapy and biotherapy).
Lonsurf (development code TAS-102) is a new antimetabolite compound drug, which is composed of anti-tumor nucleoside analog FTD (trifluridine) and thymidine phosphorylase inhibitor TPI (tipiracil). Among them, FTD can replace thymine directly into the DNA double-strand during DNA replication, which leads to DNA dysfunction and interferes with the synthesis of cancer cell DNA; TPI can inhibit thymus phosphorylase related to FTD decomposition and reduce FTD degradation, Maintain the blood concentration of 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 tykktarmskreft (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.
Tidligere ble Lonsurf godkjent av de japanske reguleringsmyndighetene i mars 2014; i Europa sendte Otsuka inn en søknad om notering for Lonsurf til EU i mars i år, og selskapet har signert en avtale med partneren Servier. For avtalen på 130 millioner dollar vil Servier være ansvarlig for det kommersielle salget av Lonsurf på det kontinentale Europa. .
Markedet for global kolorektal kreft (CRC) vil nå 9.4 milliarder dollar i 2020.
I følge forskningsrapporten som ble utgitt av det globale markedsundersøkelsesfirmaet GBI Research, vil det globale markedet for tykktarmskreft (CRC) opprettholde en liten og stabil vekst de neste årene (2014-2020) og nå 9.4 milliarder amerikanske dollar innen 2020. prognoseperiode var den sammensatte årlige vekstraten (CAGR) 1.8%, og markedsverdien av markedet i 2013 var 8.3 milliarder dollar.
The report pointed out that this growth will mainly occur in eight major developed countries, including the United States, Japan, Canada, and five European countries (the United Kingdom, France, Germany, Spain, and Italy). In 2013, the United States had the largest share of the global colorectal cancer (CRC) treatment market, accounting for 44.1%, followed by Japan (14.7%) and Germany (11.9%), and Spain (4.1%) with the lowest market share. These countries are expected to grow at a slower rate, with the exception of Japan, which will grow at a faster rate (CAGR of 5%).
Rapporten påpekte at i løpet av prognoseperioden utløper Roche-blockbuster-medikamentet Avastin (generisk navn: bevacizumab, bevacizumab) og Merck (Merck KGaA) blockbuster-medikament Erbitux (generisk navn: cetuximab), Cetuximab) i store markeder. markedsaksept av billig biosimilars, som vil begrense veksten i det globale markedet for behandling av kolorektal kreft. Roche kjemoterapeutiske medikament Xeloda (Xeloda, generisk navn: capecitabin, capecitabin) generiske legemidler som er oppført i store markeder, forventes også å begrense veksten i det globale markedet for behandling av kolorektal kreft.
However, GBI analyst Saurabh Sharma pointed out that even if the Avastin patent expires, the drug will maintain its leading position in the global colorectal cancer (CRC) treatment market until 2020. Saurabh explained that Avastin is currently widely used in first-line and second-line treatment of colorectal cancer, regardless of the K-Ras status of the patient. Although related epidermal growth factor receptor (EGFR) inhibitors have been marketed for the treatment of K-Ras wild-type tumorer ; Avastin vil fortsette å dominere markedet i behandlingen av metastatisk K-Ras villtype og mutant svulst status.
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.
Rapporten påpekte også at det i prognoseperioden (2014-2020) forventes at flere nye medisiner fra rørledninger vil komme på markedet, inkludert Lillys monoklonale antistoff Cyramza (ramucirumab), Boehringer Ingelheims trippel angiokinaseinhibitor nintedanib, XBiotech. . Imidlertid vil disse legemidlene komme inn i den meget konkurransedyktige andre- og tredje- og fjerde-linjebehandlingen og vil ikke ha stor innvirkning på hele markedet. Merkevarer som for øyeblikket er på markedet vil fortsette å ha markedsdominans da de er inkludert i tidligere og mer lønnsomme førstelinjebehandlinger.
