HUTCHMED Secures Breakthrough Therapy for ORPATHYS® and TAGRISSO® Combination for Lung Cancer Treatment
Thursday, December 12, 2024
HUTCHMED has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib).
ORPATHYS® is an oral MET inhibitor targeting a range of solid tumours, including lung, kidney, and gastric cancers. It was conditionally approved in China for patients with MET exon 14 skipping alterations and has been included in the country’s National Reimbursement Drug List since early 2023. A supplementary application is under review to expand its indications to treatment-naïve patients.
TAGRISSO® is an EGFR TKI widely used globally to manage NSCLC, including cases with central nervous system metastases. Supported by robust clinical data, TAGRISSO® is a standard treatment across multiple stages of EGFR mutation-positive NSCLC and continues to be explored in combination therapies.
This designation applies to the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET amplification, following progression on EGFR inhibitor therapy.
The NMPA grants BTD to therapies addressing serious or life-threatening diseases, especially where existing treatments are ineffective and clinical data show potential advantages over current options. The designation allows for accelerated development and review, aiming to meet unmet patient needs efficiently.
ORPATHYS® is a MET tyrosine kinase inhibitor (TKI) targeting MET aberrations, while TAGRISSO® is a third-generation EGFR TKI. The treatment combination is under evaluation in the SACHI trial, a multi-centre, open-label, randomised Phase III study being conducted in China.
Lung cancer remains the leading cause of cancer deaths worldwide, with non-small cell lung cancer (NSCLC) accounting for the majority of cases. Most patients with NSCLC are diagnosed at an advanced stage, and MET amplification or overexpression is a recognised resistance mechanism to EGFR inhibitors, including osimertinib.
The Breakthrough Therapy Designation for ORPATHYS® and TAGRISSO® underscores the potential of innovative, targeted therapies in addressing treatment-resistant lung cancers.
Source: hutch-med.com
