Pyrotinib
Pyrotinib is China's HER2 pill, widely used there with capecitabine and as a comparator for the new Chinese HER2 ADCs.
Pyrotinib is Jiangsu Hengrui's HER2 TKI. PHOEBE (vs lapatinib + capecitabine): PFS 12.5 vs 6.8 months; PHILA (first-line with trastuzumab + docetaxel): PFS 24.3 vs 10.4 months. Approved in China (2018, 2020s expansions); not approved in the US or EU. Control arm of HORIZON-Breast01.
- Route
- Oral
- Schedule
- 400 mg once daily with capecitabine
- Monitoring
- Diarrhoea
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: pyrotinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2018 | HER2+ advanced breast cancer with capecitabine |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Diarrhoea | 95% | 31% |
| Hand-foot syndrome | 60% | — |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Pyrotinib" OR ABSTRACT:"Pyrotinib" OR TITLE:"Airuini" OR ABSTRACT:"Airuini") 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 Pyrotinib, not a curated reading list.