Overseas Marketing of Fruquintinib Accelerated as It Receives the FDA’s Fast Track Designation

Hutchison MediPharma’s targeted anticancer drug: fruquintinib has recently received the Fast Track designation granted by the FDA for the treatment of patients with metastatic colorectal cancer (mCRC).

Receiving the Fast Track designation, one of the accelerated review and approval procedures established by the FDA, means the pharmaceutical product will receive more attention from the FDA in the R&D and registration processes so that the new drug R&D and marketing time will be shortened. The FDA’s Fast Track designation received by Hutchison MediPharma’s fruquintinib will undoubtedly accelerate the marketing of the drug in the U.S. to bring a new therapeutic regimen to overseas mCRC patients.

New hope of targeted therapy to Chinese patients with advanced colorectal cancer

It is reported that the new cases and death cases of colorectal cancer in China reach about 376,000 and 191,000 every year, with both the morbidity and mortality ranking 5th among all malignant tumors.

As a quinazoline small-molecule, highly selective, oral inhibitor against vascular endothelial growth factor receptors (VEGFRs), fruquintinib mainly targets VEGFR kinase family; it inhibits the proliferation, migration and tube formation of vascular endothelial cells by inhibiting VEGFR phosphorylation on the surface of vascular endothelial cells and downstream signal transduction, thereby inhibiting the tumor angiogenesis and ultimately inhibiting tumor growth.

First approved for marketing in China in Sep. 2018, with the trade name of Elunate, fruquintinib is used to treat patients with mCRC that have been previously treated with chemotherapy based on fluoropyrimidine, oxaliplatin, and irinotecan, including those who have previously received or are unsuitable for anti-vascular endothelial growth factor (VEGF) therapy and/or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type), which brings new hope of targeted therapy to the broad Chinese patients with advanced colorectal cancer. If you are looking for medical products online, then Pharmasources would be your best choice for there are many medical product suppliers and companies on Pharmasources.

Breaking through the predicament of the third-line treatment of mCRC

The multicenter, randomized, double-blind, placebo-controlled phase III study FRESCO of fruquintinib in China aimed to assess the drug’s efficacy and safety in mCRC patients who failed two lines of standard chemotherapy.

According to the data, the median overall survival (OS) of patients in the fruquintinib group was 9.3 months, 2.7 months significantly longer than that of the placebo group, with death risk reduced by 35%; the median progression-free survival (PFS) of patients in the fruquintinib group was 3.7 months, significantly longer than the 1.8 months of the placebo group, with the disease progression or death risk reduced by 74%, disease control rate of up to 62.2% and median disease stable time of up to 5.5 months. The study results reached all preset endpoints, and the clinical therapeutic results broke through the previous predicament of the third-line treatment of mCRC.

It is noteworthy that the full-text study of FRESCO was published in The Journal of the American Medical Association, making it the first clinical study of a new Chinese oncology drug published in an international top medical journal, showing the international academia’s recognition of fruquintinib.

Improving the drug accessibility with the NRDL support

It is important to note that clinically, almost half of all colorectal cancer patients are at the advanced stage when they are first diagnosed. Before the marketing of fruquintinib, there were limited effective treatment means after the failure of traditional first-line and second-line standard treatments, and the primary goal of patient treatment was still to prolong survival and improve quality of life.

According to the NRDL (National Reimbursement Drug List of China) negotiation results and latest NRDL released in Nov. 2019, fruquintinib is included in the Category B List of the NRDL with the price reduced by 68%, which will significantly reduce the financial burden on patients. The NRDL support will improve the drug accessibility to benefit more patients in China and improve their quality of life.

Clinical trial layout of fruquintinib in China

According to the information displayed on the China Drug Clinical Trial Registration and Information Publicity Platform, fruquintinib has been registered for 17 clinical trials in China. Besides colorectal cancer approved, the clinical indications also cover non-small cell lung cancer (NSCLC), advanced gastric cancer, and advanced gastric or GEJ adenocarcinoma, etc. Wherein, there are two phase III clinical studies separately regarding fruquintinib monotherapy for non-squamous NSCLC and fruquintinib in combination with paclitaxel for advanced gastric or GEJ adenocarcinoma, which are expected to be its new indications applied for marketing in China after colorectal cancer.
   In combined therapeutic regimens, the efficacy of fruquintinib in combination with anti-PD-1 monoclonal antibodies is worth looking forward to. Fruquintinib has so far been conducted the combination studies with BeiGene’s tislelizumab, Innovent Biologics’s sintilimab, and Genor BioPharma’s genolimzumab.

Overseas phase III clinical study: FRESCO-2

Besides the clinical studies in China, Hutchison MediPharma has initiated a global multicenter, blank control phase III clinical study: FRESCO-2 overseas, which plans to recruit 522 subjects to evaluate the safety and effectiveness of fruquintinib as a third-line treatment for mCRC patients, with the primary endpoint being the overall survival (OS) of patients.

According to the plan, this FRESCO-2 clinical study is expected to be completed by the end of 2022, and data from the study will be used to support the registration and marketing of fruquintinib overseas.

About  the Author:    

Xiaoyaowan, a pharmaceutical industry practitioner, a word carrier in the We-media era focusing on changes of the pharma industry.