Lonsurf for the treatment of refractory metastatic colorectal cancer

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Japanese pharmaceutical company Otsuka (Otsuka) recently received good news in the US regulatory aspects, FDA approved anti-cancer compound new drug Lo 3 ​​months in advancensurf (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 colorectal cancer (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.

Previously, Lonsurf was approved by the Japanese regulatory authorities in March 2014; in Europe, Otsuka submitted a listing application for Lonsurf to the European Union in March this year, and the company has signed an agreement with its partner Servier For the $ 130 million agreement, Servier will be responsible for the commercial sale of Lonsurf in continental Europe.

Global colorectal cancer (CRC) treatment market will reach $ 9.4 billion in 2020.

According to the research report released by global market research company GBI Research, the global colorectal cancer (CRC) treatment market will maintain a small and stable growth in the next few years (2014-2020), reaching 9.4 billion US dollars by 2020 In the forecast period, the compound annual growth rate (CAGR) was 1.8%, and the market value of the market in 2013 was $ 8.3 billion.

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%).

The report pointed out that during the forecast period, the Roche blockbuster drug Avastin (generic name: bevacizumab, bevacizumab) and Merck (Merck KGaA) blockbuster drug Erbitux (generic name: cetuximab) , Cetuximab) patents in major markets expire, will promote the market acceptance of low-cost biosimilars, which will limit the growth of the global colorectal cancer treatment market. The Roche chemotherapeutic drug Xeloda (Xeloda, generic name: capecitabine, capecitabine) generic drugs listed in major markets is expected to also limit the growth of the global colorectal cancer treatment market.

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 tumors ; Avastin will continue to dominate its market in the treatment of metastatic K-Ras wild-type and mutant tumors 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.

The report also pointed out that during the forecast period (2014-2020), several new pipeline drugs are expected to land on the market, including Lilly’s monoclonal antibody Cyramza (ramucirumab), Boehringer Ingelheim’s triple angiokinase inhibitor nintedanib, XBiotech The company’s monoclonal antibody Xilonix. However, these drugs will enter the highly competitive second-line and third- and fourth-line treatments and will not have a major impact on the entire market. Branded drugs that are currently on the market will continue to enjoy market dominance as they are included in earlier and more profitable first-line treatments.

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