Odomzo (Sonidegib)

Hedgehog Pathway Inhibitor for Locally Advanced Basal Cell Carcinoma

Rx – Prescription Only ATC: L01XJ02 Hedgehog Pathway Inhibitor
Active Ingredient
Sonidegib (as phosphate)
Available Forms
Hard capsules
Strengths
200 mg
Common Brands
Odomzo
Medically reviewed | Last reviewed: | Evidence level: 1A
Odomzo (sonidegib) is a targeted cancer medicine used to treat adults with locally advanced basal cell carcinoma (laBCC) that cannot be treated with surgery or radiation therapy, or that has returned after such treatments. It works by blocking the Hedgehog signalling pathway, which is abnormally activated in basal cell carcinoma cells, thereby preventing cancer cell growth and proliferation.
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Quick Facts About Odomzo

Active Ingredient
Sonidegib
(as phosphate salt)
Drug Class
HPI
Hedgehog Pathway Inhibitor
ATC Code
L01XJ02
Antineoplastic Agent
Common Uses
laBCC
Locally Advanced Basal Cell Carcinoma
Available Forms
Capsules
200 mg hard capsules
Prescription Status
Rx Only
Prescription required

Key Takeaways About Odomzo (Sonidegib)

  • Targeted cancer therapy: Odomzo specifically blocks the Hedgehog signalling pathway, which drives the growth of basal cell carcinoma when abnormally activated
  • Strict pregnancy prevention: Sonidegib can cause severe birth defects – women must use two forms of contraception during treatment and for 20 months after the last dose
  • Take on an empty stomach: Do not eat for 2 hours before and 1 hour after taking Odomzo, as food significantly increases drug absorption
  • Monitor for muscle problems: Serious musculoskeletal side effects including rhabdomyolysis can occur – report any unexplained muscle pain or weakness immediately
  • Very long half-life: Sonidegib has an elimination half-life of approximately 28 days, meaning it stays in the body for months after the last dose

What Is Odomzo and What Is It Used For?

Odomzo (sonidegib) is a targeted anticancer medicine used to treat adults with locally advanced basal cell carcinoma (laBCC) that has spread locally and cannot be treated with surgery or radiation therapy. It belongs to a class of drugs called Hedgehog pathway inhibitors.

Basal cell carcinoma (BCC) is the most common type of skin cancer worldwide, accounting for approximately 80% of all non-melanoma skin cancers. While most BCCs are successfully treated with surgery, a small proportion of cases become locally advanced, meaning the tumour has grown extensively into surrounding tissues, making surgical removal impractical or excessively disfiguring. In these cases, targeted drug therapy with a Hedgehog pathway inhibitor such as sonidegib offers an important treatment option.

The normal growth and development of cells is regulated by a complex network of chemical signalling pathways. One of these is the Hedgehog (Hh) signalling pathway, which plays a critical role during embryonic development by controlling cell growth, differentiation, and tissue patterning. In healthy adults, the Hedgehog pathway is largely inactive. However, in the vast majority of basal cell carcinomas, genetic mutations – most commonly in the PTCH1 (Patched 1) or SMO (Smoothened) genes – lead to constitutive (permanently on) activation of this pathway, driving uncontrolled cell proliferation and tumour growth.

Sonidegib works by selectively binding to and inhibiting Smoothened (SMO), a key transmembrane protein in the Hedgehog signalling cascade. Under normal circumstances, the Patched receptor keeps SMO inactive. When Patched is mutated or absent (as in most BCCs), SMO becomes constitutively active, sending growth-promoting signals to the cell nucleus via GLI transcription factors. By blocking SMO, sonidegib effectively shuts down the aberrant Hedgehog signalling, thereby preventing cancer cells from growing and dividing.

The efficacy of Odomzo was demonstrated in the pivotal BOLT (Basal Cell Carcinoma Outcomes with LDE225 Treatment) trial, a multicentre, randomised, double-blind phase 2 study. In this trial, the 200 mg once-daily dose demonstrated an objective response rate (ORR) of approximately 56% in patients with locally advanced BCC, with a median duration of response exceeding 26 months. These results led to regulatory approvals by the U.S. Food and Drug Administration (FDA) in 2015 and the European Medicines Agency (EMA) in 2015.

Good to know:

Odomzo is one of only two Hedgehog pathway inhibitors approved for the treatment of advanced basal cell carcinoma. The other is vismodegib (Erivedge). While both target the same pathway by inhibiting SMO, they have different chemical structures, pharmacokinetic profiles, and side effect patterns. Your oncologist or dermatologist will determine which treatment is most appropriate for your individual case.

What Should You Know Before Taking Odomzo?

Before starting Odomzo, you must inform your doctor about all your medical conditions, medications, and whether you are pregnant, may be pregnant, or planning to become pregnant. Sonidegib can cause severe birth defects and is strictly contraindicated during pregnancy and breastfeeding.

Odomzo is a powerful targeted therapy with significant potential risks that require careful consideration before and during treatment. Your prescribing physician will provide you with a patient information brochure and a patient reminder card as part of the Odomzo Pregnancy Prevention Programme. It is essential that you read and understand these materials thoroughly before beginning treatment.

Contraindications

You should not take Odomzo if any of the following apply to you:

  • Allergy to sonidegib or any of the other ingredients in the capsule – symptoms of a severe allergic reaction include difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat, and severe skin rash with itching
  • Pregnancy or suspected pregnancy – sonidegib can cause severe birth defects (teratogenicity) or death of the unborn baby by disrupting the Hedgehog signalling pathway, which is essential for normal embryonic development
  • Breastfeeding – it is not known whether sonidegib passes into breast milk, and a risk to the nursing infant cannot be excluded
  • Women of childbearing potential who are unable or unwilling to comply with the pregnancy prevention measures outlined in the Odomzo Pregnancy Prevention Programme

Warnings and Precautions

Talk to your doctor or pharmacist before taking Odomzo if you have or have had any of the following conditions:

  • History of muscle problems – sonidegib can cause serious musculoskeletal adverse reactions, including muscle cramps, muscle pain, and muscle weakness. In rare cases, a condition called rhabdomyolysis (breakdown of muscle tissue) can occur, which may lead to kidney damage. Certain medications, particularly statins and fibrates used for high cholesterol, can increase this risk
  • Kidney problems – impaired kidney function may increase the risk of complications from musculoskeletal side effects
  • Liver problems – your doctor may need to monitor liver function tests during treatment
Important safety warnings:

Do not donate blood during treatment with Odomzo and for 20 months after the last dose. If you are male, do not donate sperm during treatment or for 6 months after the last dose. Your doctor will regularly examine your skin for another type of cancer called cutaneous squamous cell carcinoma (cSCC). Report any new skin changes to your doctor promptly. Never give this medicine to anyone else, and return any unused capsules to your pharmacy after treatment ends.

Blood Tests During Treatment

Your doctor will perform blood tests before you start treatment and periodically during treatment. These tests are used to monitor your muscle health by measuring creatine phosphokinase (CPK) levels in your blood. CPK is an enzyme released from damaged muscle cells, and elevated levels can indicate muscle injury. If your CPK levels rise significantly, your doctor may need to temporarily interrupt treatment, reduce the dose, or discontinue Odomzo permanently.

Children and Adolescents

Odomzo must not be given to children and adolescents under 18 years of age. Problems with growing teeth and bones have been observed with this class of medicines. Hedgehog pathway inhibitors can cause premature closure of growth plates (epiphyseal fusion), which may result in the permanent cessation of bone growth. This effect can potentially occur even after treatment has been discontinued, given the very long half-life of the drug.

Pregnancy and Breastfeeding

Pregnancy: Do not take Odomzo if you are pregnant, think you may be pregnant, or are planning to become pregnant during treatment or within 20 months after your last dose. You must stop taking Odomzo and contact your doctor immediately if you become pregnant or suspect you may be pregnant. Sonidegib can cause severe birth defects (malformations) and may also cause foetal death. Your doctor will provide you with detailed information about the effects of sonidegib on the unborn child as part of the Odomzo Pregnancy Prevention Programme.

Breastfeeding: Do not breastfeed during treatment or for 20 months after the last dose. It is unknown whether sonidegib passes into human breast milk, and a risk to the nursing infant cannot be excluded. Given the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated throughout treatment.

Fertility: Odomzo may affect fertility in both men and women. If you are planning to have children in the future, discuss this with your doctor before starting treatment. The long half-life of sonidegib means that the drug may persist in the body for many months after discontinuation.

Contraception Requirements for Women and Men

Women of childbearing potential: Before treatment begins, your doctor will verify whether you could become pregnant, even if you have reached menopause. If you are of childbearing potential, you must:

  • Use two effective methods of contraception – one highly effective method (such as an intrauterine device or surgical sterilisation) and one barrier method (such as a condom, preferably with spermicide, or a diaphragm with spermicide)
  • Continue using both contraceptive methods for 20 months after your last dose, because traces of the medicine remain in the body for a very long time
  • Have pregnancy tests performed at least 7 days before treatment starts, every month during treatment, and as directed after treatment ends

Men: While taking Odomzo, you must always use a condom (with spermicide if available) during sexual intercourse with a female partner, even if you have had a vasectomy. You must continue using condoms for 6 months after your last dose. Tell your doctor immediately if your partner becomes pregnant during treatment or within 6 months after your treatment ends.

Driving and Operating Machinery

Odomzo is unlikely to affect your ability to drive or use machinery. However, if you experience any side effects that could impair your ability to drive safely – such as fatigue, dizziness, or muscle pain – you should refrain from driving until the symptoms resolve. Consult your doctor if you are unsure.

How Does Odomzo Interact with Other Drugs?

Odomzo can interact with a range of medications, including statins, certain antifungals, HIV medications, antibiotics, anti-epileptics, and herbal supplements. Always inform your doctor about all medications you are taking, including over-the-counter products and herbal remedies, before starting Odomzo.

Sonidegib is primarily metabolised by the liver enzyme CYP3A4. Drugs that inhibit CYP3A4 can increase sonidegib blood levels and potentially enhance its toxicity, while drugs that induce CYP3A4 can reduce sonidegib levels and decrease its effectiveness. Additionally, some medications share overlapping toxicity profiles with sonidegib (particularly regarding muscle damage), and their combination may significantly increase the risk of adverse effects.

Major Interactions

Major Drug Interactions with Odomzo (Sonidegib)
Drug Category Effect Recommendation
Ketoconazole / Itraconazole / Posaconazole / Voriconazole Antifungal agents Strong CYP3A4 inhibitors that significantly increase sonidegib blood levels Avoid concurrent use if possible; if necessary, use with extreme caution and close monitoring
Ritonavir / Saquinavir HIV protease inhibitors Strong CYP3A4 inhibitors; substantially increase sonidegib exposure Avoid combination; discuss alternative HIV treatments with your doctor
Rifampicin / Rifabutin Antibiotics (tuberculosis) Strong CYP3A4 inducers that significantly reduce sonidegib effectiveness Avoid combination; sonidegib may be ineffective
Carbamazepine / Phenytoin / Phenobarbital Anti-epileptic drugs Strong CYP3A4 inducers that reduce sonidegib blood levels Avoid combination; alternative anti-epileptic medications may be needed
Statins (simvastatin, atorvastatin, etc.) and fibrates Cholesterol-lowering agents Increased risk of serious muscle problems (rhabdomyolysis) due to additive myotoxicity Use with extreme caution; monitor CPK levels closely; consider alternatives

Moderate Interactions

Moderate Drug Interactions with Odomzo (Sonidegib)
Drug Category Effect Recommendation
Telithromycin Antibiotic (ketolide) CYP3A4 inhibitor; increases sonidegib levels Use with caution; monitor for increased side effects
Niacin (Vitamin B3) Vitamin / lipid-lowering agent May increase risk of myopathy when combined with sonidegib Monitor for muscle symptoms; report any unexplained muscle pain
Methotrexate / Mitoxantrone / Irinotecan / Topotecan Chemotherapy agents Potential for additive toxicity; altered drug transport Consult your oncologist; close monitoring required
Chloroquine / Hydroxychloroquine Antimalarials / immunomodulators Potential for additive myopathy risk Monitor for muscle symptoms; report any pain or weakness
Nefazodone Antidepressant Strong CYP3A4 inhibitor; increases sonidegib levels Avoid combination; consider alternative antidepressant
St. John’s Wort (Hypericum perforatum) Herbal supplement CYP3A4 inducer that may reduce sonidegib effectiveness Do not use during treatment with Odomzo
Penicillamine Anti-rheumatic agent Potential for additive muscle-related toxicity Discuss risks and benefits with your doctor

During treatment with Odomzo, you should inform your doctor or pharmacist if you are prescribed any new medication that you have not previously taken. This is important because the full spectrum of potential drug interactions with sonidegib is not yet completely characterised, and your medical team needs to be aware of all substances you are taking.

What Is the Correct Dosage of Odomzo?

The recommended dose of Odomzo is 200 mg (one capsule) taken once daily on an empty stomach. Do not eat for at least 2 hours before and 1 hour after taking the capsule. Swallow the capsule whole – do not open, chew, or crush it.

Always take Odomzo exactly as your doctor or pharmacist has instructed. If you are unsure about any aspect of your treatment, consult your prescribing physician or pharmacist before making any changes.

Adults

Locally Advanced Basal Cell Carcinoma

Recommended dose: 200 mg (1 capsule) once daily

Administration: Take on an empty stomach – no food for 2 hours before and 1 hour after the dose

Timing: Take the capsule at approximately the same time each day

Method: Swallow the capsule whole with water. Do not open, chew, or crush the capsule. Avoid contact with the capsule contents as this may have harmful effects.

Treatment should continue for as long as your doctor prescribes. Do not change the dose without consulting your doctor. If you vomit after swallowing the capsule, do not take additional capsules until the next scheduled dose.

Children and Adolescents (Under 18 years)

Not Recommended

Odomzo must not be used in patients under 18 years of age. Hedgehog pathway inhibitors can interfere with normal bone and dental development, potentially causing irreversible growth plate closure (epiphyseal fusion) and cessation of bone growth. These effects may persist even after treatment discontinuation.

Elderly Patients

No dose adjustment is required for elderly patients. In clinical trials, patients up to 92 years of age received the standard 200 mg dose. However, elderly patients may be more susceptible to certain side effects, particularly musculoskeletal adverse reactions. Close monitoring of CPK levels and muscle symptoms is recommended.

Dose Adjustments

Your doctor may need to interrupt your treatment or adjust your dose based on how well you tolerate Odomzo, particularly if you develop:

  • Elevated CPK levels – treatment may be temporarily withheld until levels return to normal
  • Muscle symptoms – unexplained muscle pain, cramps, or weakness may require dose interruption
  • Other significant side effects – your doctor will weigh the benefits of continued treatment against the risks

Missed Dose

If you forget to take a dose of Odomzo, take it as soon as you remember. However, if more than 6 hours have passed since the dose was due, skip the missed dose and take the next dose at your usual scheduled time. Do not take a double dose to make up for the missed one.

Overdose

In case of overdose:

If you have taken too much Odomzo, or if someone else has accidentally taken your medicine, contact your doctor or go to the nearest emergency department immediately. Take the medicine packaging and this leaflet with you so that medical staff can identify the product. Overdose symptoms may include an increase in the severity of known side effects, particularly muscle-related symptoms.

Stopping Treatment

Do not stop taking Odomzo without first talking to your doctor. Your oncologist will determine the appropriate duration of treatment based on your tumour response, overall health, and tolerability of the medication. Premature discontinuation may allow the cancer to progress.

What Are the Side Effects of Odomzo?

Like all medicines, Odomzo can cause side effects, although not everybody gets them. The most common side effects include muscle spasms, hair loss, altered taste, fatigue, nausea, muscle pain, diarrhoea, decreased appetite, weight loss, and headache. Serious muscle problems including rhabdomyolysis can occur and require immediate medical attention.

Odomzo can cause severe birth defects. You must not become pregnant while taking this medicine. See the “Pregnancy and Breastfeeding” and “Contraception Requirements” sections above for detailed information.

Seek immediate medical attention if you experience:

Difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat, or severe skin rash with intense itching – these may be signs of a serious allergic reaction. Also contact your doctor immediately if you experience severe muscle cramps, muscle pain, or muscle weakness, as this may be a sign of rhabdomyolysis (muscle tissue breakdown). Dark-coloured urine, reduced urine output, or no urine at all may indicate that muscle fibre breakdown is damaging the kidneys.

Very Common

May affect more than 1 in 10 people

  • Muscle spasms and muscle cramps
  • Muscle pain (myalgia)
  • Pain in bones, ligaments, and tendons (musculoskeletal pain)
  • Absence of menstrual periods (amenorrhoea)
  • Diarrhoea or heartburn
  • Decreased appetite
  • Headache
  • Altered taste or unusual taste in the mouth (dysgeusia)
  • Abdominal pain
  • Nausea
  • Vomiting
  • Itching (pruritus)
  • Hair loss (alopecia)
  • Fatigue
  • General pain
  • Weight loss

Common

May affect up to 1 in 10 people

  • Upset stomach or indigestion (dyspepsia)
  • Constipation
  • Skin rash
  • Abnormal hair growth (in unusual locations)
  • Dehydration – symptoms include thirst, reduced urine, weight loss, dry and flushed skin, irritability

Abnormal Blood Test Results

Detected through routine monitoring

  • Elevated creatine phosphokinase (CPK) – indicates muscle cell damage
  • Elevated lipase and/or amylase – indicates potential pancreatic stress
  • Elevated ALT and/or AST – indicates liver function changes
  • Elevated creatinine – indicates kidney function changes
  • High blood sugar (hyperglycaemia)
  • Low haemoglobin (needed for oxygen transport)
  • Low white blood cell count

The musculoskeletal side effects of Odomzo are among the most clinically significant. Muscle cramps and myalgia are very common and can sometimes be severe enough to require dose reduction or treatment interruption. In rare cases, patients may develop rhabdomyolysis, a serious condition in which damaged muscle tissue releases proteins (myoglobin) into the bloodstream, potentially leading to kidney failure. Your doctor will monitor your CPK levels regularly and may order additional blood tests if you report muscle symptoms.

Hair loss (alopecia) and altered taste perception (dysgeusia) are also very common during treatment and are related to the mechanism of action of Hedgehog pathway inhibitors, as the Hedgehog pathway plays a role in hair follicle maintenance and taste bud renewal. These effects are generally reversible after treatment discontinuation, though recovery may take several months given the long half-life of the drug.

Reporting side effects:

It is important to report suspected side effects after the medicine has been authorised. This allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients can report suspected adverse reactions to their national pharmacovigilance authority (e.g. the FDA MedWatch programme in the United States, the Yellow Card Scheme in the United Kingdom, or the EMA EudraVigilance system in Europe).

How Should You Store Odomzo?

Store Odomzo below 30°C in the original packaging to protect from moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the packaging.

Proper storage of Odomzo is essential to maintain its effectiveness and safety. Follow these storage guidelines carefully:

  • Temperature: Store at or below 30°C (86°F). Do not freeze the capsules.
  • Packaging: Keep the capsules in the original blister packaging to protect them from moisture.
  • Expiry date: Do not use Odomzo after the expiry date (EXP) stated on the carton and blister. The expiry date refers to the last day of the stated month.
  • Keep out of reach of children: Store the medicine where children cannot see or reach it.
  • Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
  • Unused capsules: Return any unused capsules to your pharmacy after your treatment has ended. Never give this medicine to anyone else.

What Does Odomzo Contain?

Each Odomzo capsule contains 200 mg of sonidegib (as phosphate) as the active ingredient, along with several inactive excipients. The capsules are pink, opaque, and marked with “SONIDEGIB 200MG” and “NVR”.

Understanding the full composition of your medicine can be important, particularly if you have known allergies or intolerances to specific excipients. The complete contents of each Odomzo 200 mg capsule are as follows:

Active Ingredient

Sonidegib (as phosphate) 200 mg – the active substance that exerts the therapeutic effect by inhibiting the Hedgehog signalling pathway.

Inactive Ingredients (Excipients)

  • Capsule contents: Crospovidone type A, lactose monohydrate, magnesium stearate, poloxamer 188, colloidal anhydrous silica, sodium lauryl sulfate
  • Capsule shell: Gelatin, red iron oxide (E172), titanium dioxide (E171)
  • Printing ink: Black iron oxide (E172), propylene glycol (E1520), shellac
Lactose warning:

Odomzo contains lactose monohydrate (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Appearance and Pack Sizes

Odomzo 200 mg capsules are pink and opaque, imprinted with “SONIDEGIB 200MG” and “NVR”. They are supplied in perforated unit-dose blisters containing 10 × 1 capsules, available in packs of 10 or 30 capsules. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Odomzo is manufactured and marketed by Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH Hoofddorp, Netherlands. The medicine was originally developed by Novartis and subsequently transferred to Sun Pharmaceuticals. For further information about this medicine, contact the marketing authorisation holder.

Frequently Asked Questions About Odomzo

Basal cell carcinoma (BCC) is the most common type of skin cancer. It usually develops on sun-exposed areas of skin and grows slowly. Most cases are treated successfully with surgery. However, in some cases, the tumour grows extensively into surrounding tissues (locally advanced BCC), making it impossible to remove surgically or treat with radiation. Odomzo is specifically designed for these advanced cases, offering a targeted oral therapy that blocks the molecular pathway driving cancer cell growth.

Food, particularly high-fat meals, significantly increases the absorption of sonidegib from the gut. This can lead to unpredictably high drug levels in your blood, which increases the risk of side effects – particularly muscle-related problems. By taking Odomzo on an empty stomach (no food for 2 hours before and 1 hour after), the drug absorption is more consistent and predictable, allowing your doctor to better manage dosing and side effects.

In the pivotal BOLT clinical trial, Odomzo 200 mg daily demonstrated an objective response rate of approximately 56% in patients with locally advanced basal cell carcinoma. This means that more than half of patients experienced a meaningful reduction in their tumour size. The median duration of response exceeded 26 months, indicating that responses tend to be durable. Complete responses (total tumour disappearance) were observed in a proportion of patients. However, individual results vary, and your oncologist will monitor your response through regular clinical examinations.

Muscle pain (myalgia) is one of the most common side effects of Odomzo. If you experience mild muscle discomfort, inform your doctor at your next appointment. However, if you develop severe, unexplained muscle pain, tenderness, or weakness – especially if accompanied by dark-coloured urine – you should contact your doctor immediately. These could be signs of rhabdomyolysis, a serious condition requiring urgent medical evaluation and potentially treatment discontinuation. Your doctor will monitor your creatine phosphokinase (CPK) blood levels regularly to detect early signs of muscle damage.

Sonidegib blocks the Hedgehog signalling pathway, which is essential for normal embryonic development. Exposure during pregnancy can cause severe birth defects or foetal death. The contraception requirements are particularly extended (20 months for women, 6 months for men after the last dose) because sonidegib has an exceptionally long elimination half-life of approximately 28 days. This means the drug remains in the body at potentially harmful concentrations for many months after you stop taking it. The 20-month period corresponds to approximately five half-lives, which is the standard timeframe needed for essentially complete drug elimination from the body.

Both Odomzo (sonidegib) and Erivedge (vismodegib) are Hedgehog pathway inhibitors that work by blocking the Smoothened (SMO) receptor. While they share the same target, they are different chemical compounds with distinct pharmacokinetic profiles. Sonidegib has a significantly longer half-life (approximately 28 days versus 4 days for vismodegib), which means it persists in the body for much longer after discontinuation. The side effect profiles are broadly similar, though differences exist in frequency and severity. The choice between the two drugs depends on individual patient factors, tumour characteristics, and physician experience. No head-to-head comparative trials have been conducted.

References

This article is based on the following peer-reviewed sources and official regulatory documents:

  1. European Medicines Agency (EMA). Odomzo (sonidegib) – Summary of Product Characteristics (SmPC). Last updated 2024. Available from: EMA – Odomzo
  2. U.S. Food and Drug Administration (FDA). Odomzo (sonidegib) Prescribing Information. Approved July 2015, revised 2023. Available from: FDA Drug Database.
  3. Dummer R, Guminksi A, Gutzmer R, et al. The 42-month analysis of the BOLT trial of sonidegib in advanced basal cell carcinoma. British Journal of Dermatology. 2020;182(3):649–656. doi:10.1111/bjd.18369
  4. Lear JT, Migden MR, Lewis KD, et al. Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study. Journal of the European Academy of Dermatology and Venereology. 2018;32(3):372–381. doi:10.1111/jdv.14542
  5. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Basal Cell Skin Cancer. Version 2.2024.
  6. Migden MR, Guminski A, Gutzmer R, et al. Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncology. 2015;16(6):716–728. doi:10.1016/S1470-2045(15)70100-2
  7. World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023.
  8. British National Formulary (BNF). Sonidegib. Last updated 2024. Available from: BNF Online.

Medical Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, comprising specialists in oncology, dermatology, and clinical pharmacology with documented academic backgrounds and clinical experience.

Content Development

Written by medical professionals with expertise in oncological pharmacology and skin cancer treatment, following the GRADE evidence framework.

Medical Review

Independently reviewed by the iMedic Medical Review Board according to international guidelines from EMA, FDA, NCCN, and WHO.

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