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The trial that made dalpiciclib the first Chinese CDK4/6 inhibitor approved, more than doubling the time before breast cancer grew when added to fulvestrant.
361 patients randomised 2:1. Median progression-free survival 15.7 versus 7.2 months (hazard ratio 0.42), published in Nature Medicine 2021, with neutropenia the main toxicity. NMPA approval December 2021; DAWNA-2 (first line with an aromatase inhibitor) followed in 2023. It reproduced the PALOMA-3 and MONALEESA-3 pattern with a domestic, reimbursed drug.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Shares Cancer Hospital, Chinese Academy of Medical Sciences and the tag china.
Shares Cancer Hospital, Chinese Academy of Medical Sciences and the tag china.
Shares Jiangsu Hengrui Pharmaceuticals and the tag china.
Shares Jiangsu Hengrui Pharmaceuticals and the tag china.
Shares Jiangsu Hengrui Pharmaceuticals and the tag china.
Shares Jiangsu Hengrui Pharmaceuticals and the tag china.
Shares HR-positive / HER2-negative breast cancer and the tag china.
Shares Jiangsu Hengrui Pharmaceuticals and the tag china.