LONDON (dpa-AFX) - China has granted conditional approval for AstraZeneca (AZN.L, AZN) and HUTCHMED's Orpathys or savolitinib for treatment of patients with non-small cell lung cancer or NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
The approval was based on positive results from a single-arm Phase II trial conducted in China in patients with NSCLC with this mutation, including patients with the PSC subtype.
Orpathys demonstrated robust anti-tumour activity based on an independent review of objective response rate in the trial's primary endpoint and its disease control rate.
As part of the joint global development program with HUTCHMED, Orpathys is being evaluated in combination with Tagrisso and other medicines to address tumour mechanisms of resistance in NSCLC in the ORCHARD and SAVANNAH Phase II trials for the combinations to provide longer duration of benefit, and as a treatment for other MET-driven tumours, including papillary renal cell carcinoma, and gastric and gastroesophageal junction cancers.
Copyright RTT News/dpa-AFX
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