News

HUTCHMED has announced that the China National Medical Products Administration (NMPA) have granted a priority review for a new drug application (NDA).

The NDA will cover the combination of TAGRISSO (osimertinib) and ORPATHYS (savolitinib) in the treatment of adult patients with ‘locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET amplification after disease progression on first-line EGFR therapy’, according to the press release.

The acceptance of this NDA will trigger a milestone payment from pharmaceutical giant AstraZeneca.

Dr Michael Shi, head of R&D and chief medical officer of HUTCHMED stated: “This marks the first regulatory filing for the ORPATHYS and TAGRISSO combination. The combination has demonstrated clear evidence to address MET-driven EGFR-inhibitor resistance and offers a continued path for oral treatment. With our biomarker-specific approach, we are hopeful to enhance treatment continuity and quality of life for NSCLC patients navigating this challenging journey. We and our partner AstraZeneca have been exploring this combination globally, through an array of late-stage clinical trials including the TATTON, SAVANNAH, SAFFRON and ORCHARD studies, and we hope to bring this all-oral, chemotherapy-free treatment option to patients with MET-driven lung cancer in the near future.”

The phase 3 multi-centre randomised, controlled open-label clinical trial termed SACHI, provided data that influenced the decision from NMPA. SACHI aimed to evaluate the safety and efficacy of highly selective MET tyrosine kinase inhibitor (TKI) drug ORPATHYS in combination with irreversible EGFR TKI, TAGRISSO compared to the standard-of-care treatment, a platinum-based doublet chemotherapy.

The predetermined primary endpoint of progression-free survival was met. This was determined at a planned interim analysis.