Hutchmed Limited announced on Tuesday (April 18) that its new drug application (NDA) for fruquintinib in combination with paclitaxel of second-line advanced or gastric gastroesophageal junction adenocarcinoma has taken a step forward in its development.
The cancer grows from cells that make mucus and is similar to other types of esophogeal cancers.
Michael Shi, head of R&D and chief medical officer of Hutchmed said: “The NMPA acceptance of our NDA for fruquintinib is a positive step towards addressing the significant unmet medical need for gastric cancer patients.”
He said gastric cancer is one of the most common cancers globally, with the highest incidence and mortality rates found in Asian populations.
Shi added: “China alone accounts for over 40% of all new gastric cancer cases in the world. Despite recent advancement in the first line setting, there are few treatments available for patients whose disease progressed on initial therapy.
“Fruquintinib has demonstrated clinically meaningful benefit for patients in the phase 3 FRUTIGA study, and we are excited by the possibility of providing a potential new oral treatment option for patients in China.”
The NDA is supported by data from the randomized, double-blind, phase 3 study which is evaluating fruquintinib combined with paclitaxel compared with paclitaxel monotherapy, for second-line treatment of advanced gastric cancer.
In China, fruquintinib is approved under the brand name Elunate and is included in the China National Reimbursement Drug List (NRDL).
In March 2023, the company and Takeda Pharmaceutical Company Limited closed an exclusive license agreement to further the global development, commercialization and manufacture of fruquintinib outside China.
The study enrolled approximately 700 patients. Its dual-primary endpoints were progression-free survival (PFS) and overall survival (OS). The trial met the PFS endpoint at a statistically and clinically meaningful level. While there was an improvement in median OS, the OS endpoint was not statistically significant per the pre-specified statistical plan. Fruquintinib also demonstrated a statistically significant improvement in secondary endpoints including objective response rate (ORR), disease control rate (DCR) and duration of response (DoR). The safety profile of fruquintinib in the study was consistent with previously reported studies.
Fruquintinib has been generally well tolerated in patients to date and is being investigated in combinations with other anti-cancer therapies.
It was approved for marketing by the NMPA in September 2018 and commercially launched in China in November 2018 under the brand name Elunate for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan. It has been included in the NRDL since January 2020.
The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated.
Filing of a rolling submission of NDA to the U.S. Food and Drug Administration (FDA) was completed in March 2023. Submissions to the European Medicines Agency (EMA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA) are expected to be completed in 2023.
