Zai Lab (ZLAB) said Tuesday that its Tumor Treating Fields therapy for patients with pancreatic cancer received an Innovative Medical Device Designation from China's National Medical Products Administration.
The company said that the designation was awarded based on "positive" results from its phase 3 PANOVA-3 trial, which had tested the use of the therapy simultaneously with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone.
Zai Lab said the designation enables the company to make use of an expedited approval procedure. The company said it is on track for a regulatory submission in China in H2 2025.
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