Hutchmed withdraws supplemental new drug application in China

30th Aug 2024 10:53

(Sharecast News) - Hutchmed China has voluntarily withdrawn its supplemental new drug application (NDA) in China for the use of fruquintinib in combination with paclitaxel for second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma, it announced on Friday.

The AIM-traded firm said the decision followed an internal review and recent discussions with China's National Medical Products Administration (NMPA), which indicated that the current data package would likely not support approval.

It said the NDA was based on data from the phase three 'FRUTIGA' study, which showed positive results, particularly in progression-free survival (PFS), one of the primary endpoints.

Although there was also an improvement in median overall survival (OS), the second primary endpoint, it was not statistically significant.

Further analyses suggested that the OS outcome could have been confounded by a high and imbalanced proportion of patients receiving subsequent antitumour therapies.

Despite that, the combination of fruquintinib and paclitaxel demonstrated a meaningful clinical benefit and a favourable safety profile, the board said.

However, discussions with the Centre for Drug Evaluation (CDE) of the NMPA and its external committee members highlighted that the current understanding of the OS results was insufficient for the approval of the supplemental NDA.

As a result, Hutchmed decided to withdraw the application and explore alternative approaches.

Fruquintinib is already approved in China, the US, and Europe for treating metastatic colorectal cancer, and is undergoing regulatory reviews in other jurisdictions.

Additionally, an NDA for fruquintinib combined with sintilimab in endometrial cancer had been accepted for priority review in China, and a phase three trial for its use in renal cell carcinoma recently completed enrollment.

"Whilst disappointed by this outcome, we remain optimistic about the utility of fruquintinib in the treatment of gastric cancer," said Hutchmed's chief executive and chief scientific officer, Dr Weiguo Su.

"The data set from FRUTIGA demonstrates that fruquintinib plus paclitaxel could offer a promising new treatment option to certain patients in future, and we are driven to investigate this possibility thoroughly.

"We look forward to evaluating a path forward and would like to thank both the patients and principal investigators who took part in this study for contributing to a better understanding of this devastating disease."

At 1036 BST, shares in Hutchmed China were down 4.07% at 259p.

Reporting by Josh White for Sharecast.com.