HutchMed Initiates Rolling NDA Submission for Elunate to US FDA

Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the initiation of a rolling submission of a New Drug Application (NDA) to the US FDA for Elunate (fruquintinib) for the treatment of refractory metastatic colorectal cancer (CRC). HutchMed plans to complete the NDA submission in the first half of 2023, to be followed by a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) and an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Fruquintinib, a highly selective and potent oral inhibitor of VEGFR-1, -2, and -3, was granted Fast Track Designation status from the US FDA for its use against metastatic CRC in June 2020, enabling the company to submit sections of the NDA on a rolling basis.

Clinical Trial and Data
The NDA is supported by the global Phase III multi-regional clinical (MRCT) FRESCO-2 study trial conducted in the US, Europe, Japan, and Australia. The study investigated fruquintinib plus best supportive care (BSC) vs placebo plus BSC in patients with refractory metastatic CRC. The study demonstrated that treatment with fruquintinib resulted in a statistically significant and clinically meaningful increase in the primary endpoint of overall survival (OS) and the key secondary endpoint of progression-free survival (PFS) compared to treatment with a placebo. Specifically, the median OS was 7.4 months for the 461 patients treated with fruquintinib compared to 4.8 months for the 230 patients in the placebo group (hazard ratio [HR] 0.66; 95% confidence interval [CI] 0.55–0.80; p<0.001). The median PFS was 3.7 months for patients treated with fruquintinib compared to 1.8 months for patients in the placebo group (HR 0.32; 95% CI 0.27–0.39; p<0.001). The disease control rate (DCR) was 55.5% in the fruquintinib group compared to 16.1% for patients in the placebo group. The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported fruquintinib studies.

Drug Profile and Future Prospects
Fruquintinib is a vascular endothelial growth factor receptor (VEGFR) 1/2/3 inhibitor that won a first market approval in China in September 2018 as a third-line treatment for colorectal cancer (CRC). The drug was added to the National Reimbursement Drug List (NRDL) at the beginning of 2020. HutchMed is partnering with Eli Lilly & Co. on the commercialization of the product in China, while retaining all rights outside of the country. The molecule is also being assessed in advanced gastric cancer or adenocarcinoma of gastroesophageal junction, and is the focus of multiple clinical collaborations between HutchMed, BeiGene, and Innovent Bio.-Fineline Info & Tech

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