Alpelisib
Alpelisib was the first PI3K drug for PIK3CA-mutant breast cancer (2019). It is effective, but high blood sugar and rash limited its use, and newer drugs are displacing it.
SOLAR-1: PFS 11.0 vs 5.7 months with fulvestrant in PIK3CA-mutant disease. Hyperglycaemia (grade 3-4 ~37%), rash, and diarrhoea are frequent; requires metformin prophylaxis strategies. Superseded in first-line endocrine-resistant disease by inavolisib and in the unselected AKT-pathway-altered population by capivasertib.
- Route
- Oral
- Schedule
- 300 mg once daily with fulvestrant
- Dose modifications
- Reduce to 250 then 200 mg for hyperglycaemia/rash
- Monitoring
- Fasting glucose and HbA1c before and during; antihistamine prophylaxis for rash
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. PIK3CA mutation by an approved test required.
- Assistance programmes
- Novartis Patient Support (Patient Assistance NOW Oncology)
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Appraised for
- With fulvestrant for PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer after a CDK4/6 inhibitor
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA816 · SMC advice: alpelisib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2019 | PIK3CA-mutant HR+/HER2- advanced breast cancer with fulvestrant after endocrine therapy |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Hyperglycaemia | 64% | 37% |
| Diarrhoea | 58% | 7% |
| Rash | 36% | 10% |
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:"Alpelisib" OR ABSTRACT:"Alpelisib" OR TITLE:"Piqray" OR ABSTRACT:"Piqray") 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 Alpelisib, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductInavolisib
Shares PI3K/AKT-pathway inhibitor + endocrine therapy (± CDK4/6), PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, Small-molecule kinase inhibitors.
- ProductCapivasertib
Shares Hyperglycaemia (PI3K/AKT inhibitor class effect), PI3K/AKT-pathway inhibitor + endocrine therapy (± CDK4/6), PIK3CA / PI3K-alpha, PI3K / AKT / mTOR.
- ProductGedatolisib
Shares PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, Small-molecule kinase inhibitors, HR-positive / HER2-negative breast cancer.
- ProductUmbralisib
Shares PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, Small-molecule kinase inhibitors.
- ProductDuvelisib
Shares PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, Small-molecule kinase inhibitors.
- ProductCopanlisib
Shares PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, Small-molecule kinase inhibitors.
- TermEndocrine resistance
Shares Hyperglycaemia (PI3K/AKT inhibitor class effect), PIK3CA / PI3K-alpha, HR-positive / HER2-negative breast cancer.
- ProductIdelalisib
Shares PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, Small-molecule kinase inhibitors.