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Dalpiciclib is Hengrui's CDK4/6 inhibitor, the first China-developed drug of the class, approved for hormone-driven advanced breast cancer on the DAWNA trials.
DAWNA-1 (361 patients, Nature Medicine 2021) showed median progression-free survival of 15.7 versus 7.2 months when dalpiciclib was added to fulvestrant after endocrine therapy (hazard ratio 0.42), the basis of NMPA approval in December 2021; DAWNA-2 with an aromatase inhibitor in the first line followed in 2023. Neutropenia is frequent, as with palbociclib. It gives Chinese patients a reimbursed domestic alternative to imported CDK4/6 inhibitors.
Selective inhibitor of cyclin-dependent kinases 4 and 6, preventing RB phosphorylation and G1 to S progression in hormone receptor-positive breast cancer. Connects to CDK4/6.
1.Dalpiciclib slips into a pocket on CDK4/6.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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| Region | Year | Indication |
|---|---|---|
| China | 2021 | HR-positive, HER2-negative advanced breast cancer with fulvestrant after endocrine therapy (DAWNA-1) |
| China | 2023 | First-line HR-positive, HER2-negative advanced breast cancer with an aromatase inhibitor (DAWNA-2) |
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Query for this drug: (TITLE:"Dalpiciclib" OR ABSTRACT:"Dalpiciclib" OR TITLE:"Airuikang" OR ABSTRACT:"Airuikang" OR TITLE:"SHR6390" OR ABSTRACT:"SHR6390") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Dalpiciclib, not a curated reading list.
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