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(Sharecast News) - Hutchmed China announced a significant milestone in its cancer treatment work on Thursday, with the supplemental new drug application (sNDA) for savolitinib had been accepted for review by the China National Medical Products Administration (NMPA).
The AIM-traded firm said the application was targeting adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) featuring mesenchymal epithelial transition factor (MET) exon 14 skipping alteration.
If approved, the application would expand the label indication for savolitinib to include treatment-naive patients in China.
Savolitinib, previously granted conditional approval in China for treating NSCLC patients with MET exon 14 skipping alterations who had progressed following prior systemic therapy or who were ineligible for chemotherapy, had been marketed under the brand name 'Orpathys' by Hutchmed's partner AstraZeneca.
That, the board sid, represented a groundbreaking development as the first selective MET inhibitor approved in China.
Given that a significant portion of lung cancer patients globally, and particularly in China, exhibited NSCLC with MET exon 14 skipping alterations, the expansion of savolitinib's indication held considerable promise for addressing an unmet medical need.
The acceptance of the sNDA followed the presentation of preliminary efficacy and safety data from the first-line cohort of the confirmatory phase 3b clinical trial at the IASLC World Conference on Lung Cancer in September.
Subsequently, the final data from the trial were presented at the European Lung Cancer Congress on 20 March.
Noteworthy outcomes from the phase 3b trial included an objective response rate (ORR) of 62.1% and 39.2% in treatment-naïve and previously-treated patients, respectively, along with favourable disease control rates and median durations of response.
Moreover, the safety profile of savolitinib was found to be tolerable, with no new safety signals observed.
The global licensing and collaboration agreement between AstraZeneca and Hutchmed, initiated in 2011, sees Hutchmed spearheading the drug's development in China, while AstraZeneca leads development efforts outside of China with responsibility for commercialisation worldwide.
At 1203 GMT, Hutchmed China shares were down 1.13% at 261.51p.
Reporting by Josh White for Sharecast.com.
