HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013), a China-based biopharmaceutical company, has announced the withdrawal of its New Drug Application (NDA) for fruquintinib, a VEGFR inhibitor, in combination with paclitaxel for the second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) in China. The decision to withdraw was made following discussions with the National Medical Products Administration (NMPA), which suggested that the current data would not likely secure approval.
Fruquintinib, targeting VEGF receptors 1, 2, and 3, is already approved in China, the U.S., and Europe for metastatic colorectal cancer (CRC). The drug is marketed by Takeda as Fruzqala outside of China, while Eli Lilly co-markets it with HutchMed in China under the brand name Elunate.
The NDA submission for GC/GEJ was supported by the Phase III FRUTIGA study, which showed a median progression-free survival (PFS) of 5.6 months for the combination therapy versus 2.7 months for paclitaxel alone. Although there was an improvement in median overall survival (OS) from 8.4 months to 9.6 months, this did not reach statistical significance. The NMPA’s Center for Drug Evaluation (CDE) communicated that they would not consider further statistical modeling that suggested a meaningful clinical benefit and favorable OS trends for the combination therapy.
Dr. Su Weiguo Su, CEO and CSO of HutchMed, expressed continued optimism regarding the potential of fruquintinib in gastric cancer treatment. The company plans to engage in further discussions with regulatory authorities to determine the necessary steps for a future filing and is conducting subgroup analyses. In April 2024, an NDA for fruquintinib in combination with the PD-1 inhibitor sintilimab for endometrial cancer was accepted with priority review in China. Additionally, a Phase III trial for fruquintinib combined with sintilimab in renal cell carcinoma is fully enrolled and ongoing in China. – Fineline.com
