Itovebi (Inavolisib)
Selective PI3K-Alpha Inhibitor for PIK3CA-Mutated Breast Cancer
Quick Facts About Itovebi
Key Takeaways
- Itovebi (inavolisib) is a first-in-class selective PI3K-alpha inhibitor specifically designed to target the mutant p110-alpha protein produced by the PIK3CA gene in breast cancer cells.
- It is approved for use only in patients with confirmed PIK3CA-mutated, HR+/HER2− locally advanced or metastatic breast cancer, in combination with palbociclib and fulvestrant.
- Hyperglycaemia (high blood sugar) is the most clinically significant side effect and requires regular blood glucose monitoring, particularly during the first four weeks of treatment.
- The standard starting dose is 9 mg once daily, taken orally with or without food, and treatment continues as long as there is clinical benefit.
- Genetic testing to confirm PIK3CA mutation status is mandatory before initiating treatment, ensuring the drug targets the correct molecular pathway.
What Is Itovebi and What Is It Used For?
Quick Answer: Itovebi (inavolisib) is a targeted cancer medicine that selectively blocks the PI3K-alpha protein, which drives tumour growth in certain breast cancers. It is used alongside palbociclib and fulvestrant to treat adults with PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
Itovebi contains the active substance inavolisib, which belongs to a group of medicines called PI3K inhibitors (phosphatidylinositol 3-kinase inhibitors). These medicines work by targeting specific enzymes within cancer cells that are responsible for cell growth and survival signalling. Inavolisib represents a significant advancement in precision oncology because it was specifically designed to selectively inhibit the alpha isoform of PI3K, reducing the off-target effects that limited earlier, less selective PI3K inhibitors.
The PI3K signalling pathway is one of the most frequently altered pathways in breast cancer. Approximately 40% of HR+/HER2− breast cancers harbour activating mutations in the PIK3CA gene, which encodes the p110-alpha catalytic subunit of PI3K. These mutations cause the PI3K-alpha protein to become overactive, sending continuous growth signals to cancer cells even in the absence of normal growth factors. This overactivity promotes uncontrolled cell proliferation, survival, and resistance to endocrine therapies such as tamoxifen or aromatase inhibitors.
How Itovebi Works
Inavolisib works by selectively blocking the activity of the mutant p110-alpha protein produced by the PIK3CA gene. By inhibiting this overactive protein, inavolisib disrupts the PI3K/AKT/mTOR signalling cascade that cancer cells depend on for growth and survival. This targeted approach means that inavolisib preferentially affects cancer cells carrying the PIK3CA mutation while having a reduced impact on normal cells, leading to a more favourable side-effect profile compared to pan-PI3K inhibitors.
The selectivity of inavolisib for the mutant form of PI3K-alpha is a key distinguishing feature. Earlier PI3K inhibitors, such as alpelisib, also target PI3K-alpha but do so without differentiating between the wild-type and mutant forms. Inavolisib's enhanced selectivity for the mutant enzyme means it can inhibit cancer-driving signalling more effectively while potentially reducing toxicity associated with inhibiting the normal, wild-type PI3K-alpha protein found in healthy tissues, particularly in insulin signalling pathways.
Approved Indications
Itovebi is specifically indicated for the treatment of adults with hormone receptor-positive (ER+), HER2-negative locally advanced or metastatic breast cancer that carries a PIK3CA mutation. The medication is prescribed when the cancer has recurred during or within 12 months of completing adjuvant endocrine therapy. In patients who have previously received a CDK4/6 inhibitor, at least 12 months must have elapsed since completing that prior CDK4/6 inhibitor treatment before starting Itovebi.
Combination Therapy
Itovebi is not used as a standalone treatment. It is always administered in combination with palbociclib (a CDK4/6 inhibitor) and fulvestrant (a selective oestrogen receptor degrader). This triple combination targets multiple pathways simultaneously: inavolisib blocks PI3K-alpha signalling, palbociclib inhibits cell-cycle progression via CDK4/6, and fulvestrant blocks and degrades oestrogen receptors. Together, these three agents create a comprehensive blockade of the key growth-driving pathways in HR+ breast cancer.
In pre-menopausal women and in men, the combination therapy also includes a luteinising hormone-releasing hormone (LHRH) agonist such as goserelin or leuprolide to suppress ovarian or testicular hormone production, ensuring complete endocrine suppression.
What Should You Know Before Taking Itovebi?
Quick Answer: Before taking Itovebi, inform your doctor about any history of diabetes, high blood sugar, or kidney problems. Itovebi must not be taken if you are allergic to inavolisib. Regular blood glucose monitoring is essential, and pregnancy must be avoided during treatment.
Contraindications
You must not take Itovebi if you are allergic (hypersensitive) to inavolisib or any of the other ingredients in the tablet. The inactive ingredients include lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and various film-coating components. If you have a known intolerance to lactose, inform your doctor before starting treatment as the tablets contain lactose monohydrate.
Warnings and Precautions
Before and during treatment with Itovebi, there are several important warnings and precautions that both patients and healthcare providers need to be aware of. The two most clinically significant adverse effects are hyperglycaemia (high blood sugar) and stomatitis (mouth inflammation), both of which can become severe if not properly managed.
Hyperglycaemia is the most important safety concern with Itovebi. PI3K-alpha plays a critical role in insulin signalling, so inhibiting this enzyme disrupts normal glucose metabolism. Before starting inavolisib, tell your doctor if you have ever had high blood sugar levels, diabetes, or signs of hyperglycaemia such as excessive thirst, dry mouth, frequent urination, increased urine volume, fatigue, nausea, increased appetite with weight loss, blurred vision, or feeling faint. Your doctor will measure your blood glucose levels before starting treatment and regularly during therapy, particularly during the first four weeks when the risk is highest.
Your doctor may also ask you to monitor your blood sugar at home during treatment. If you are unsure how to measure your blood glucose, your healthcare team will provide guidance. Based on the results, your doctor may prescribe glucose-lowering medications, pause your treatment, reduce your dose, or permanently discontinue Itovebi if hyperglycaemia cannot be adequately controlled.
Stomatitis (inflammation and sores in the mouth) is another very common side effect that can significantly impact quality of life. Tell your doctor immediately if you develop mouth pain, redness, swelling, or ulcers. Early intervention with supportive care measures can help manage symptoms effectively.
Also inform your doctor if you have any kidney problems, as this may affect how the drug is processed by your body and may require additional monitoring.
Children and Adolescents
Itovebi should not be given to children and adolescents under 18 years of age. The safety and efficacy of inavolisib have not been established in this age group, and the approved indication (HR+/HER2− metastatic breast cancer with PIK3CA mutation) is an adult-onset malignancy that is exceedingly rare in paediatric populations.
Drug Interactions
Tell your doctor or pharmacist about all medicines you are taking, including prescription drugs, over-the-counter medications, and herbal supplements. Inavolisib can affect or be affected by other drugs, particularly those metabolised by the same liver enzyme pathways. Important interactions include medicines such as alfentanil (pain medication), astemizole (antihistamine), cisapride (for heartburn), paclitaxel (cancer chemotherapy), quinidine (heart rhythm medication), warfarin (blood thinner), phenytoin and S-mephenytoin (anti-seizure medications), and immunosuppressants such as cyclosporine, sirolimus, and tacrolimus.
| Interacting Drug | Drug Category | Interaction Effect | Clinical Advice |
|---|---|---|---|
| Alfentanil | Opioid analgesic | Altered drug levels due to CYP3A4 interaction | Monitor for increased or decreased efficacy; dose adjustment may be needed |
| Paclitaxel | Chemotherapy (taxane) | Potential increase in paclitaxel levels | Close monitoring required; inform oncologist of all treatments |
| Warfarin | Anticoagulant | Altered anticoagulant effect | Increased INR monitoring; dose adjustments may be needed |
| Phenytoin / S-Mephenytoin | Antiepileptic | Altered seizure control or inavolisib levels | Monitor seizure control and drug levels closely |
| Quinidine | Antiarrhythmic | Potential for increased quinidine concentrations | Monitor heart rhythm; avoid if possible |
| Cyclosporine | Immunosuppressant | Altered immunosuppressant levels | Therapeutic drug monitoring recommended |
| Sirolimus / Tacrolimus | Immunosuppressant | Altered immunosuppressant levels | Close monitoring of drug levels and renal function |
| Cisapride / Astemizole | GI motility / Antihistamine | Risk of QT prolongation | Avoid concomitant use due to cardiac risk |
Pregnancy and Breastfeeding
Pregnancy: You must not take Itovebi if you are pregnant. Based on its mechanism of action and preclinical data, inavolisib may cause harm to an unborn baby. If you are of childbearing potential, your doctor will verify that you are not pregnant before starting treatment, which may include a pregnancy test. Tell your doctor immediately if you become pregnant during treatment. If you or your partner are planning to have children, consult your doctor or pharmacist before starting inavolisib.
Contraception: Women of childbearing potential must use effective non-hormonal contraception during treatment and for at least one week after the last dose. Non-hormonal methods are required because Itovebi is used alongside endocrine therapies that may interact with hormonal contraceptives. Men with female partners who are or may become pregnant must use condoms during treatment and for one week after the last dose.
Breastfeeding: Do not breastfeed during treatment with Itovebi and for at least one week after the last dose. It is not known whether inavolisib passes into breast milk, and a risk to the nursing infant cannot be excluded.
Driving and Using Machines
Itovebi may affect your ability to drive and use machines. If you feel tired while taking this medicine, exercise particular caution when driving or operating machinery. Do not drive or use machines until you are sure that your ability to perform these activities is not affected by the medication.
Important Information About Excipients
Itovebi tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to certain sugars, speak to your doctor before taking this medicine. The tablets also contain less than 1 mmol (23 mg) of sodium per film-coated tablet, meaning they are essentially sodium-free.
What Is the Correct Dosage of Itovebi?
Quick Answer: The recommended starting dose of Itovebi is 9 mg taken once daily as a tablet, with or without food. Your doctor may reduce the dose to 6 mg or 3 mg if you experience side effects. The tablet should be swallowed whole and not crushed or chewed.
Always take Itovebi exactly as your doctor or pharmacist has instructed. Do not change your dose or stop taking Itovebi without consulting your healthcare provider first. The treatment is individualised based on your response and tolerability, and your doctor will determine the dose that is right for you.
Adults
Standard Dosing
The recommended starting dose is 9 mg once daily, taken orally with or without food. This is achieved by taking one 9 mg film-coated tablet or three 3 mg film-coated tablets. Taking the dose at the same time each day helps establish a consistent routine and maintain steady drug levels.
Dose Reductions
If you experience certain side effects, your doctor may reduce your dose in a stepwise manner:
- First dose reduction: 6 mg once daily
- Second dose reduction: 3 mg once daily
Your doctor may also temporarily pause (interrupt) treatment and then resume at the same or a lower dose. If side effects remain unmanageable at 3 mg daily, your doctor may decide to permanently discontinue Itovebi.
| Dose Level | Daily Dose | Tablet Configuration | Notes |
|---|---|---|---|
| Starting dose | 9 mg once daily | 1 × 9 mg tablet or 3 × 3 mg tablets | Recommended initial dose for all patients |
| First reduction | 6 mg once daily | 2 × 3 mg tablets | Used when side effects require dose adjustment |
| Second reduction | 3 mg once daily | 1 × 3 mg tablet | Minimum effective dose; discontinue if not tolerated |
How to Take Itovebi
Itovebi should be taken once daily, with or without food. The tablet must be swallowed whole — do not chew, crush, or split the tablet before swallowing. Do not swallow any tablet that is broken, cracked, or otherwise damaged, as you may not receive the full dose. If you notice damage to the tablet, discard it and take a new one from the blister pack.
Children
Itovebi is not approved for use in children and adolescents under 18 years of age. No clinical studies have been conducted in this population, and the indicated condition is virtually non-existent in paediatric patients.
Elderly
No specific dose adjustments are required for elderly patients based solely on age. However, elderly patients may be more susceptible to certain side effects, particularly hyperglycaemia and fatigue. Your doctor will monitor you closely and adjust the dose as needed based on your individual response and tolerability.
Missed Dose
If you miss a dose of Itovebi, you can still take it up to 9 hours after the scheduled time. If more than 9 hours have passed since you should have taken the dose, skip the missed dose for that day and take your next dose at the regular time the following day. Do not take a double dose to make up for a missed dose.
If you vomit shortly after taking a dose, do not take an additional dose that day. Take your normal dose at the usual time the next day.
Overdose
If you take more Itovebi than prescribed, contact your doctor immediately or go to a hospital emergency department. Take the medicine packaging and patient information leaflet with you so that the healthcare team knows what you have taken. Symptoms of overdose may include severe hyperglycaemia, nausea, vomiting, and other dose-dependent adverse effects.
Duration of Treatment
Itovebi is a long-term treatment that may continue for months or years. Your doctor will regularly assess your condition to determine whether treatment is providing benefit. Continue taking Itovebi every day for as long as your doctor tells you to. Do not stop taking this medicine unless your doctor instructs you to, as stopping treatment may allow your cancer to progress.
What Are the Side Effects of Itovebi?
Quick Answer: The most common side effects of Itovebi include high blood sugar (hyperglycaemia), mouth inflammation (stomatitis), diarrhoea, low platelet counts, fatigue, anaemia, nausea, rash, and decreased appetite. Hyperglycaemia is the most clinically important side effect and requires regular blood glucose monitoring.
Like all medicines, Itovebi can cause side effects, although not everybody gets them. Some side effects can be serious and require immediate medical attention. Your doctor may need to treat these symptoms, temporarily pause your treatment, reduce your dose, or permanently stop Itovebi depending on the severity.
Serious Side Effects
- Hyperglycaemia (very common): difficulty breathing, nausea and vomiting lasting more than 2 hours, abdominal pain, extreme thirst or dry mouth, frequent urination or larger urine volumes, blurred vision, abnormally increased appetite, unexplained weight loss, fruity-smelling breath, facial flushing, dry skin, unusual drowsiness or fatigue
- Stomatitis (very common): pain, redness, swelling, or ulcers in the mouth
- Ketoacidosis (uncommon): difficulty breathing, headache, nausea, vomiting — a serious complication of high blood sugar causing high ketone levels in the blood
Side Effects by Frequency
Very Common
May affect more than 1 in 10 people
- Hyperglycaemia (high blood sugar)
- Stomatitis (inflammation and sores in the mouth)
- Diarrhoea
- Thrombocytopenia (low platelet count, causing unusual bruising or bleeding)
- Fatigue and tiredness
- Anaemia (low red blood cell count, causing tiredness and pale skin)
- Nausea
- Skin rash
- Decreased appetite
- Headache
- Alopecia (hair loss or thinning)
- Weight loss
- Elevated alanine aminotransferase (liver enzyme, detected via blood test)
- Low potassium levels (detected via blood test)
- Abdominal pain
- Vomiting
- Dry skin
- Urinary tract infection
Common
May affect up to 1 in 10 people
- Low calcium levels (detected via blood test)
- Dry eyes
- Dyspepsia (indigestion)
- Elevated insulin levels (detected via blood test)
- Dysgeusia (altered taste)
- Dermatitis (skin inflammation with rash)
- Folliculitis (infection or inflammation of hair follicles)
Uncommon
May affect up to 1 in 100 people
- Diabetic ketoacidosis (a serious complication of high blood sugar with high blood ketone levels)
Managing Hyperglycaemia
Hyperglycaemia is the most clinically significant side effect of Itovebi and occurs because PI3K-alpha signalling is essential for normal insulin action. When inavolisib inhibits PI3K-alpha, it disrupts the cellular response to insulin, leading to elevated blood glucose levels. This is a class effect shared by all PI3K inhibitors, though the degree and management may differ between agents.
Your doctor will implement a structured blood glucose monitoring programme. During the first four weeks of treatment, monitoring will be more frequent as this is when hyperglycaemia is most likely to develop. Your doctor may advise you to drink more water during treatment to help with hydration and metabolic stability. If hyperglycaemia develops, your doctor may prescribe glucose-lowering medications such as metformin or insulin. In some cases, dose reduction or temporary treatment interruption may be necessary.
Managing Stomatitis
Stomatitis (mouth inflammation) is another very common side effect that can range from mild discomfort to severe ulceration affecting the ability to eat and drink. Preventive measures include maintaining good oral hygiene, using a soft toothbrush, and avoiding spicy, acidic, or very hot foods and drinks. If stomatitis develops, your doctor may recommend medicated mouthwashes, topical treatments, or dose modifications depending on the severity.
How Does Itovebi Interact with Other Drugs?
Quick Answer: Itovebi can interact with several medications, including pain relievers (alfentanil), blood thinners (warfarin), anti-seizure drugs (phenytoin), immunosuppressants (cyclosporine, sirolimus, tacrolimus), and certain chemotherapy agents (paclitaxel). Always inform your doctor about all medications you take.
Inavolisib is metabolised by the liver and can affect the levels and efficacy of other medicines that share similar metabolic pathways. Conversely, some medicines can alter the blood levels of inavolisib, potentially making it less effective or increasing the risk of side effects. It is crucial that your oncologist has a complete picture of all your current medications, including prescription drugs, over-the-counter remedies, vitamins, and herbal supplements.
Major Interactions
CYP3A4 substrates with narrow therapeutic indices such as alfentanil, cisapride, astemizole, and quinidine require particular caution. Inavolisib may alter the plasma concentrations of these drugs, leading to increased toxicity or reduced efficacy. For cisapride and astemizole specifically, the potential for QT prolongation (a dangerous heart rhythm disturbance) means that concomitant use should ideally be avoided.
Immunosuppressants including cyclosporine, sirolimus, and tacrolimus have narrow therapeutic windows, and changes in their blood levels can have serious clinical consequences. If you are taking any of these medicines (for example, after an organ transplant), your doctor will need to monitor drug levels closely and may adjust doses accordingly.
Warfarin is another medicine that requires careful monitoring when used with Itovebi. Inavolisib may alter the anticoagulant effect of warfarin, necessitating more frequent INR monitoring and possible dose adjustments to maintain safe and effective anticoagulation.
Minor Interactions
Anti-seizure medications such as phenytoin and S-mephenytoin may be affected by inavolisib through altered hepatic metabolism. Patients taking these medicines should have seizure control and drug levels monitored regularly. Paclitaxel, which may be used in other cancer treatment contexts, can also be affected; although paclitaxel is not typically used concurrently with the Itovebi regimen, any planned use should be discussed with your oncology team.
The list of known interacting medicines above is not exhaustive. If you are unsure whether any medicine you take could interact with Itovebi, ask your doctor or pharmacist for advice.
How Should You Store Itovebi?
Quick Answer: Store Itovebi at room temperature in the original packaging to protect from moisture. Keep out of reach of children and do not use after the expiry date. Do not use damaged or broken tablets.
Proper storage of Itovebi is essential to ensure the medication remains effective and safe throughout its shelf life. Follow these storage guidelines carefully:
- Temperature: No special temperature storage conditions are required. Store at room temperature.
- Moisture protection: Store in the original packaging (blister pack) to protect from moisture. The medication is moisture-sensitive.
- Keep out of reach: Store out of the sight and reach of children.
- Expiry date: Do not use Itovebi after the expiry date (EXP) printed on the carton and blister pack. The expiry date refers to the last day of the stated month.
- Damaged tablets: Do not use if the packaging is damaged or shows signs of tampering. Do not swallow any tablet that is broken, cracked, or otherwise not intact.
- Disposal: Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment.
What Does Itovebi Contain?
Quick Answer: Each Itovebi tablet contains inavolisib as the active substance, available in 3 mg and 9 mg strengths. The tablets also contain lactose monohydrate and other inactive ingredients for tablet formation and coating.
Active Substance
The active substance is inavolisib:
- Each 3 mg film-coated tablet contains 3 mg of inavolisib
- Each 9 mg film-coated tablet contains 9 mg of inavolisib
Inactive Ingredients (Excipients)
Tablet core (both 3 mg and 9 mg tablets): lactose monohydrate, magnesium stearate (E 470b), microcrystalline cellulose (E 460), and sodium starch glycolate.
Film coating (3 mg tablets): polyvinyl alcohol (partially hydrolysed), titanium dioxide (E 171), macrogol, talc (E 553b), and red iron oxide (E 172).
Film coating (9 mg tablets): polyvinyl alcohol (partially hydrolysed), titanium dioxide (E 171), macrogol, talc (E 553b), red iron oxide (E 172), and yellow iron oxide (E 172).
Appearance and Pack Sizes
| Strength | Colour | Shape | Markings | Size |
|---|---|---|---|---|
| 3 mg | Red | Round, convex | "INA 3" debossed on one side | Approx. 6 mm diameter |
| 9 mg | Pink | Oval | "INA 9" debossed on one side | Approx. 13 mm × 6 mm |
Itovebi film-coated tablets are supplied in cartons containing 28 × 1 film-coated tablets in perforated unit-dose blisters. The perforated blister design allows individual tablets to be separated and dispensed as needed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany.
Manufacturer: Roche Pharma AG, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany.
For further information about this medicine, contact the local representative of the marketing authorisation holder in your country. Additional information is available from the European Medicines Agency (EMA) website.
Frequently Asked Questions About Itovebi
Itovebi (inavolisib) is used to treat adults with hormone receptor-positive (HR+), HER2-negative locally advanced or metastatic breast cancer that carries a PIK3CA gene mutation. It is given in combination with palbociclib (a CDK4/6 inhibitor) and fulvestrant (an oestrogen receptor degrader) for patients whose cancer has progressed on or after endocrine therapy. Before starting treatment, a genetic test must confirm the presence of a PIK3CA mutation in the tumour.
The most common side effects (affecting more than 1 in 10 patients) include hyperglycaemia (high blood sugar), stomatitis (mouth inflammation and sores), diarrhoea, thrombocytopenia (low platelet count), fatigue, anaemia, nausea, rash, decreased appetite, headache, hair loss, weight loss, elevated liver enzymes, low potassium, abdominal pain, vomiting, dry skin, and urinary tract infection. Hyperglycaemia is the most clinically significant side effect and requires regular blood glucose monitoring.
Itovebi is taken as one tablet once daily, with or without food, at approximately the same time each day. The recommended starting dose is 9 mg. The tablet should be swallowed whole — do not chew, crush, or split it. If you miss a dose, you can take it up to 9 hours after the scheduled time. If more than 9 hours have passed, skip the missed dose and take the next dose at the usual time.
Yes, a confirmed PIK3CA gene mutation is mandatory before starting Itovebi. Your oncologist will arrange a genetic test, which can be performed on tumour tissue from a biopsy or through a liquid biopsy analysing circulating tumour DNA from a blood sample. Only patients whose cancers carry an activating PIK3CA mutation will benefit from inavolisib, as it selectively targets the mutant PI3K-alpha protein encoded by this gene.
Itovebi causes hyperglycaemia because the PI3K-alpha enzyme it inhibits is not only involved in cancer cell growth but also plays a critical role in normal insulin signalling. When inavolisib blocks PI3K-alpha, it disrupts the ability of cells to respond to insulin, which is needed to transport glucose from the blood into cells. This insulin resistance leads to elevated blood sugar levels. This is a known class effect of PI3K inhibitors. Regular monitoring and, if necessary, treatment with glucose-lowering medications can help manage this side effect effectively.
No. Itovebi must not be taken during pregnancy as it may harm the unborn child. Women of childbearing potential must use effective non-hormonal contraception during treatment and for at least one week after the last dose. Men with female partners who are or may become pregnant should use condoms during this period. Breastfeeding is also not recommended during treatment and for one week after stopping Itovebi, as it is unknown whether the drug passes into breast milk.
References
All medical information is based on peer-reviewed sources and international guidelines.
- European Medicines Agency (EMA). Itovebi (inavolisib) – Summary of Product Characteristics. Available at: ema.europa.eu/en/medicines/human/EPAR/itovebi. Accessed December 2025.
- Turner NC, Im S-A, Saura C, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024;391(17):1584-1596. doi:10.1056/NEJMoa2404625.
- André F, Ciruelos EM, Juric D, et al. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2021;32(2):208-217.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Breast Cancer. Available at: esmo.org/guidelines/breast-cancer. Accessed December 2025.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd edition. 2023.
- Juric D, Janku F, Rodón J, et al. Phosphatidylinositol 3-Kinase α-Selective Inhibition With Alpelisib (BYL719) in PIK3CA-Altered Solid Tumors: Results From the First-in-Human Study. J Clin Oncol. 2018;36(13):1291-1299.
- American Society of Clinical Oncology (ASCO). Practice Guidelines for Breast Cancer Treatment. Available at: asco.org/practice-patients/guidelines. Accessed December 2025.
Editorial Team
This article has been medically reviewed by specialists in oncology and clinical pharmacology.
Medical Writing Team
iMedic Medical Editorial Team
Specialists in Oncology and Clinical Pharmacology with expertise in breast cancer treatment and targeted therapy
Medical Review Board
Independent Expert Panel
Board-certified oncologists who review all content according to ESMO, ASCO, and international clinical practice guidelines