November 2023,Fruquintinib has been approved by the U.S. FDA for marketing in the United StatesTo be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for the treatment of metastatic colorectal cancer。This is also the first anti-tumor drug independently invented by Chinese, researched by Chinese doctors, and developed by Chinese enterprises, and this approval means that China's self-developed innovative drugs have successfully sailed!
Colorectal cancer, also known as colorectal cancer, is a highly heterogeneous disease, according to the World Health OrganizationColorectal cancer has become the third most common cancer and the second leading cause of death in the world. A 2022 study published in The Lancet Gastroenterology & Hepatology shows that the incidence and mortality of colorectal cancer have more than doubled globally over the past three decades.
There are no obvious symptoms of early-stage colorectal cancer, and some patients may have non-specific changes such as diarrhea and constipation. Patients are usually found at an advanced stage and have a poor prognosis. And due to the large number of complications of colorectal cancer and the high mortality rate of patients, the currently available ** regimen is still very limited, so patients urgently need an oral, chemotherapy-free** regimen to break the deadlock.
In September 2018, the China Food and Drug Administration approved fruquintinib for colorectal cancerBrought a new ** program for Chinese patients. As evidenced by the results of clinical studies at the time of approvalPatients treated with fruquintinib had an extended survival of up to 93 months, which significantly prolonged the life expectancy of patients in the placebo group by 27 months!
The approval of the FDA in the U.S. is based on data from two important large-scale Phase III clinical studies, including data from the international multi-center clinical trial of Fresco-2 and data from the in-house Fresco study in China.
The results of the Fresco study carried out independently in China show thatGroup A (fruquintinib + best**).Total survivalPeriod（os）For 93 months, while group B (placebo + best**).Total survivalPeriod（os）For 657 months. Similarly, in progression-free survival (PFS), Group A also demonstrated good efficacyProgression-free survivalPeriod（pfs）Up to 371 months, compared to 184 months extended by nearly 2 months.
The results of the international multi-center clinical trial FRESCO-2 showed:Median overall survival (mos) for7.4 months, 4. in the placebo groupAt 8 months, fruquintinib was significantly extended by 26 monthsOverall survival (OS).
Based on the above trial data, fruquintinib has demonstrated promising efficacy in colorectal cancer.
In November 2023,Fruquintinib in combination with sintilimab in second-line patients with locally advanced or metastatic renal cell carcinomaPatient enrollment has been completed in the Phase II and III studies in China. If positive trial results are obtained, a new drug application will also be submitted to the China Food and Drug Administration. We also look forward to benefiting more cancer patients with fruquintinib."
References: 1. Dasari A, Sobrero A, Yao J, Yoshino T, Schelman W, Yang Z, Chien C, Kania M, Tabernero J, Eng C fresco-2: a global phase iii study investigating the efficacy and safety of fruquintinib in metastatic colorectal cancer. future oncol. 2021 aug;17(24):3151-3162. doi: 10.2217/fon-2021-0202. epub 2021 may 17. pmid: 33993740.
2、zheng rs, zhang sw, zeng hm, wang sm, sun kx, chen r, li l, wei wq, he j. cancer incidence and mortality in china, 2016[j]. j natl cancer cent, 2022, 2(1): 1-9.
3. Chi-Med's official website.
4. Surgery, 9th Edition, People's Medical Publishing House, 387-394
5. Handbook of Clinical Medical Oncology 395-430, Sixth Edition, People's Medical Publishing House
6. Chinese Colorectal Cancer Diagnosis and Treatment Standards (2017 Edition).
Note: The purpose of this article is to convey more information, and it does not make any medication basis, please consult the attending physician for specific medication guidelines. If it involves the content of the work, copyright and other issues, please contact us with a message, and we will delete the content as soon as possible.