Hutchmed tumour therapy candidate gets breakthrough designation

29th Aug 2023 13:38

(Sharecast News) - Pharmaceuticals developer Hutchmed China announced on Tuesday that the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) to its investigational drug savolitinib.

The AIM-traded firm said the designation was specifically for the treatment of patients with locally-advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma, who had mesenchymal epithelial transition factor (MET) amplification and had not responded to at least two lines of standard therapies.

It said BTD status was expected to expedite the development and review process for savolitinib, making it potentially available to patients sooner than typical drug approvals.

The ongoing study of savolitinib was a phase two registration study conducted as a single-arm, multi-centre, open-label trial.

Hutchmed said the primary objective of the study was to evaluate the efficacy, safety, and tolerability of savolitinib in treating patients with MET-amplified gastric cancer or GEJ adenocarcinoma.

Around 60 patients were expected to be enrolled in the phase two trial.

"Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumours," Hutchmed explained in its statement.

"Іt blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations - such as exon 14 skipping alterations or other point mutations; gene amplification or protein overexpression."

At 1234 BST, shares in Hutchmed China were up 10.03% at 245.93p.

Reporting by Josh White for Sharecast.com.