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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 Superseded in first-line endocrine-resistant disease by inavolisib and in the unselected AKT-pathway-altered population by capivasertib.
ATP-competitive PI3Kα-selective inhibitor. Connects to PIK3CA / PI3K-alpha.
1.Alpelisib slips into a pocket on PIK3CA / PI3K-alpha.
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.
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).
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.
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.
Sources: NICE TA816 · SMC advice: alpelisib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 4.5 years later, when the FDA's table was read.
Formulation: Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.4 years later, when the FDA's table was read.
| 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.
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Query 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.
Shares Hyperglycaemia (PI3K/AKT inhibitor class effect), Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer, PI3K/AKT-pathway inhibitor + endocrine therapy (± CDK4/6), Choline metabolism in cancer.
Shares Hyperglycaemia (PI3K/AKT inhibitor class effect), A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy, PI3K/AKT-pathway inhibitor + endocrine therapy (± CDK4/6), PIK3CA mutation.
Shares Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1), HR-positive metastatic breast cancer after CDK4/6 inhibitors, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, PIK3CA / PI3K-alpha.
Shares Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer, Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer, A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy, Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1).
Shares Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation., Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer, Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer, Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation.
Shares PI3K, AKT and mTOR inhibitors, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, PIK3CA / PI3K-alpha.
Shares Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer, ER status (oestrogen receptor by IHC), Chemical carcinogenesis - receptor activation, Breast cancer (KEGG map).
Shares Hyperglycaemia (PI3K/AKT inhibitor class effect), Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer, Choline metabolism in cancer, PTEN loss.