Retsevmo: Uses, Dosage & Side Effects
A highly selective RET kinase inhibitor for the treatment of RET-altered cancers including non-small cell lung cancer, thyroid cancer, and other RET fusion-positive solid tumors
Retsevmo (selpercatinib) is a targeted oral cancer medication that belongs to the class of RET kinase inhibitors. It is specifically designed to treat cancers driven by alterations in the RET gene, including RET fusion-positive non-small cell lung cancer (NSCLC), RET-altered thyroid cancers of all types, medullary thyroid cancer with RET mutations, and other RET fusion-positive solid tumors. Selpercatinib works by selectively blocking the abnormal RET protein that drives uncontrolled tumor growth. Retsevmo is taken as an oral tablet twice daily and holds conditional marketing authorization in the European Union. It has transformed treatment options for patients with these molecularly defined cancers.
Quick Facts: Retsevmo
Key Takeaways
- Retsevmo (selpercatinib) is a highly selective RET kinase inhibitor used to treat cancers driven by RET gene alterations, including RET fusion-positive NSCLC, all types of RET-altered thyroid cancer, and RET fusion-positive solid tumors in adults and adolescents aged 12 and older.
- Before starting Retsevmo, your cancer must be confirmed to have a RET gene alteration through genetic testing; the drug is only effective in RET-driven tumors and is not a general-purpose cancer treatment.
- The dose depends on body weight: patients weighing under 50 kg take 120 mg twice daily, while those weighing 50 kg or more take 160 mg twice daily. Tablets are taken with or without food and swallowed whole.
- Regular monitoring of liver function, blood pressure, ECG, thyroid function, and blood electrolytes is essential throughout treatment, as Retsevmo can cause hepatotoxicity, hypertension, QT prolongation, and electrolyte imbalances.
- Both women and men must use effective contraception during treatment and for at least one week after the last dose, as Retsevmo may harm an unborn child and may impair fertility.
What Is Retsevmo and What Is It Used For?
Retsevmo contains the active substance selpercatinib, a precision oncology medicine designed to target a specific molecular driver of cancer. The RET (Rearranged during Transfection) gene encodes a receptor tyrosine kinase that plays a crucial role in cell growth, differentiation, and survival under normal circumstances. However, when the RET gene undergoes certain alterations – either through fusions with partner genes or activating point mutations – it produces an abnormal, constitutively active RET protein. This aberrant protein signals cells to grow and divide uncontrollably, leading to the development and progression of cancer.
Selpercatinib was designed from the outset to be a highly selective inhibitor of the RET kinase. Unlike earlier multi-kinase inhibitors that blocked RET along with many other kinases (often causing significant off-target toxicity), selpercatinib demonstrates remarkable selectivity for RET over other kinase targets. This selectivity translates into a more favorable side effect profile while maintaining potent antitumor activity. The drug binds to the ATP-binding site of the RET kinase domain, blocking its enzymatic activity and preventing the downstream signaling cascades that drive tumor cell proliferation and survival. Selpercatinib is effective against both wild-type RET and a broad range of RET alterations, including numerous fusion variants and point mutations, as well as certain acquired resistance mutations such as the RET V804L/M gatekeeper mutations.
RET alterations are found across multiple cancer types, although they are relatively uncommon. RET fusions occur in approximately 1–2% of non-small cell lung cancers (NSCLC), approximately 10–20% of papillary thyroid cancers, and at lower frequencies in various other solid tumors including pancreatic, colorectal, breast, and salivary gland cancers. RET point mutations are the primary oncogenic driver in the vast majority (approximately 60–90%) of medullary thyroid cancers, both hereditary (associated with multiple endocrine neoplasia type 2, or MEN2) and sporadic forms.
Retsevmo is approved by the European Medicines Agency (EMA) under conditional marketing authorization, by the U.S. Food and Drug Administration (FDA), and by regulatory authorities in numerous other countries for the following indications:
- RET fusion-positive non-small cell lung cancer (NSCLC): Retsevmo is indicated as monotherapy for the treatment of adults with advanced RET fusion-positive NSCLC who have not previously been treated with a RET inhibitor. The pivotal LIBRETTO-001 and LIBRETTO-431 trials demonstrated impressive overall response rates and durable responses in both treatment-naive and previously treated patients. In the randomized LIBRETTO-431 trial, selpercatinib showed superior progression-free survival compared to standard-of-care chemotherapy with or without immunotherapy as first-line treatment.
- Thyroid cancer (all histological types): Retsevmo is indicated for adults and adolescents aged 12 years and older with advanced RET fusion-positive thyroid cancer who require systemic therapy and for whom prior treatment with radioactive iodine (where appropriate) has not been effective. This covers papillary, follicular, poorly differentiated, and anaplastic thyroid cancer subtypes that harbor RET fusions.
- Medullary thyroid cancer (MTC): Retsevmo is indicated for adults and adolescents aged 12 years and older with advanced RET-mutant medullary thyroid cancer who require systemic therapy. MTC arises from the parafollicular C cells of the thyroid and is characterized by RET point mutations in the majority of cases. Selpercatinib has demonstrated high response rates in both previously treated and treatment-naive MTC patients in clinical trials.
- RET fusion-positive solid tumors: Retsevmo is indicated for adults with advanced RET fusion-positive solid tumors (tumor-agnostic indication) who have progressed on or after prior systemic treatment, or who have no satisfactory treatment alternatives. This provides a treatment option for patients with rare RET-driven cancers across different tissue types.
To confirm that Retsevmo is the right treatment, your doctor will order a validated genetic test (such as next-generation sequencing or fluorescence in situ hybridization) to detect the presence of a RET gene alteration in your tumor. This molecular testing is a prerequisite for treatment, as Retsevmo is only effective in cancers where RET signaling is the oncogenic driver.
Retsevmo represents a shift toward precision oncology, where treatment is matched to the specific molecular profile of a patient's tumor rather than the organ of origin. By targeting the RET alteration specifically, Retsevmo aims to maximize antitumor efficacy while minimizing the broad systemic toxicity associated with conventional chemotherapy or less selective kinase inhibitors.
What Should You Know Before Taking Retsevmo?
Contraindications
There are specific situations in which Retsevmo must not be used. Understanding these absolute contraindications is critical before starting treatment.
- Hypersensitivity: Do not take Retsevmo if you are allergic to selpercatinib or any of the other ingredients in the product (microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxypropyl cellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide pigments).
- Prior severe skin reactions: Do not take Retsevmo if you have previously experienced severe skin rash, peeling skin, blisters, or sores in the mouth after taking this medication. Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), have been reported.
Warnings and Precautions
Talk to your doctor before taking Retsevmo if any of the following apply to you:
- Lung or breathing problems: Retsevmo can cause serious, life-threatening inflammation of the lungs (interstitial lung disease/pneumonitis). Symptoms include new or worsening shortness of breath, cough, and fever. Your doctor will monitor you and may discontinue treatment if this occurs.
- High blood pressure (hypertension): Retsevmo can raise blood pressure. Your blood pressure will be measured before and regularly during treatment. Antihypertensive medications may be started or adjusted as needed.
- Heart rhythm disorders (QT prolongation): Retsevmo can cause an abnormality on the electrocardiogram (ECG) known as QT prolongation, which can lead to dangerous irregular heartbeats. An ECG will be performed before and periodically during treatment. Tell your doctor if you experience fainting, as this may be a symptom of QT prolongation.
- Liver problems (hepatotoxicity): Retsevmo can affect liver function, which may be serious. Your doctor will perform regular blood tests to monitor liver enzymes. Seek immediate medical attention if you develop yellowing of the skin or eyes (jaundice), dark urine, loss of appetite, nausea, vomiting, or pain in the upper right abdomen.
- Thyroid dysfunction: Retsevmo can affect thyroid function. Your doctor will monitor thyroid hormone levels before and during treatment. If you are taking levothyroxine (thyroid hormone replacement), your doctor may need to adjust the dose, as Retsevmo can reduce the effectiveness of levothyroxine.
- Fertility: Retsevmo may impair fertility in both men and women. Discuss fertility preservation options with your doctor before starting treatment if this is a concern for you.
- History of major bleeding: Retsevmo can cause bleeding events. Inform your doctor if you have previously experienced significant hemorrhage.
Stop taking Retsevmo and seek immediate medical attention if you notice reddish, non-raised spots with a target-like or circular appearance on the trunk, often with central blisters, skin peeling, or sores in the mouth, throat, nose, genitals, or eyes. These may be preceded by fever and flu-like symptoms. These are signs of Stevens-Johnson syndrome (SJS), a serious and potentially life-threatening condition.
Rapid breakdown of cancer cells may occur when taking Retsevmo, potentially causing irregular heartbeat, kidney failure, or abnormal blood test results. This risk is higher in patients with pre-existing kidney problems or low blood pressure. Your doctor will monitor you closely and may take preventive measures.
Retsevmo can cause drug hypersensitivity reactions including fever, rash, and pain. If you experience such a reaction, your doctor may prescribe corticosteroids to manage the symptoms before considering whether to continue treatment.
Pediatric Patients
Retsevmo is approved for use in adolescents aged 12 years and older for thyroid cancer indications (including medullary thyroid cancer). It is not approved for patients under 18 years of age with lung cancer. Children younger than 12 years should not be treated with this medicine for thyroid cancer.
In pediatric patients (under 18 years), Retsevmo may cause irregular growth or damage to the growth plates of the hip joint (slipped capital femoral epiphysis). If your child experiences hip or knee pain, or unexplained limping during treatment, inform the doctor immediately. Growth monitoring may be performed during treatment.
Pregnancy and Breastfeeding
Retsevmo should not be used during pregnancy because the effects on the unborn child are not known and the drug may potentially cause harm based on its mechanism of action. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Do not breastfeed during treatment with Retsevmo. It is not known whether selpercatinib passes into breast milk. Do not breastfeed for at least one week after the last dose to avoid potential harm to the nursing infant.
Both women who could become pregnant and men who could father a child must use effective contraception during treatment and for at least one week after the last dose of Retsevmo. Retsevmo may impair fertility in both men and women. Discuss fertility preservation measures with your doctor before starting treatment.
Driving and Operating Machinery
Exercise special caution when driving any vehicle or operating machinery while taking Retsevmo, as you may experience fatigue or dizziness during treatment. If you feel tired or dizzy, do not drive or operate machines until these symptoms have resolved.
Important Information About Ingredients
Retsevmo contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially sodium-free. This is relevant for patients on sodium-restricted diets.
How Does Retsevmo Interact with Other Drugs?
Selpercatinib is primarily metabolized by the CYP3A4 enzyme system. Drugs that inhibit or induce CYP3A4 can significantly alter selpercatinib blood levels, affecting both its effectiveness and safety. Additionally, selpercatinib itself can affect the levels of certain other medications. It is essential to inform your doctor about all medications, herbal supplements, and over-the-counter products you are taking before starting and during treatment with Retsevmo.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Ketoconazole, Itraconazole, Posaconazole, Voriconazole (strong CYP3A4 inhibitors) | Increased selpercatinib blood levels, greater risk of toxicity | Avoid combination if possible; dose reduction or close monitoring may be required |
| Atazanavir, Ritonavir, Cobicistat (HIV protease inhibitors / boosters) | Increased selpercatinib blood levels via CYP3A4 inhibition | Avoid combination; consult your doctor for alternative antiretroviral therapy if possible |
| Clarithromycin (macrolide antibiotic) | Increased selpercatinib blood levels via CYP3A4 inhibition | Use alternative antibiotic if possible; monitor closely for adverse effects |
| Rifampicin (strong CYP3A4 inducer) | Significantly decreased selpercatinib levels, potentially reducing efficacy | Avoid combination; anticancer effect may be substantially diminished |
| Carbamazepine (anticonvulsant / CYP3A4 inducer) | Decreased selpercatinib levels, reduced efficacy | Avoid combination; consider alternative anticonvulsant |
| St. John’s wort (herbal CYP3A4 inducer) | Decreased selpercatinib levels, reduced efficacy | Do not use St. John’s wort during treatment with Retsevmo |
Acid-Reducing Agents
Gastric acid-reducing medications can affect the absorption of selpercatinib, as the drug’s solubility depends partly on stomach pH. The management differs depending on the type of acid reducer:
- Proton pump inhibitors (PPIs) such as omeprazole or lansoprazole: If you must take a PPI, take Retsevmo with a full meal to ensure adequate absorption despite the elevated gastric pH.
- H2-receptor antagonists such as ranitidine or famotidine: Take the H2 blocker at least 2 hours after taking Retsevmo to minimize the impact on absorption.
Drugs Whose Levels May Increase with Retsevmo
| Drug | Used For | Clinical Action |
|---|---|---|
| Repaglinide | Type 2 diabetes (blood sugar control) | Monitor blood glucose closely; dose adjustment may be needed |
| Dasabuvir | Hepatitis C treatment | Use with caution; monitor for increased side effects |
| Selexipag | Pulmonary arterial hypertension | Monitor for increased side effects; dose adjustment may be needed |
| Digoxin | Heart conditions | Monitor digoxin levels; risk of toxicity at elevated levels |
| Lovastatin, Simvastatin | High cholesterol | Increased risk of muscle toxicity (myopathy/rhabdomyolysis); monitor closely |
| Dabigatran | Blood clot prevention and treatment | Increased bleeding risk; monitor for signs of hemorrhage |
| Levothyroxine | Thyroid hormone replacement | Retsevmo may reduce levothyroxine effectiveness; thyroid function monitoring required |
Always inform your healthcare team of every medication, vitamin, supplement, and herbal product you are taking. Drug interactions can change over the course of treatment, and your doctor may need to adjust dosing or switch medications to ensure both safety and effectiveness.
What Is the Correct Dosage of Retsevmo?
Always take Retsevmo exactly as prescribed by your doctor or pharmacist. The recommended dosing schedule is twice daily, approximately at the same times each day (ideally morning and evening), to maintain consistent drug levels in the body. Your doctor will determine the appropriate dose based on your body weight and may adjust it if you experience certain side effects.
Weight-Based Dosing
| Body Weight | Dose | Frequency | Maximum Daily Dose |
|---|---|---|---|
| Under 50 kg | 120 mg | Twice daily | 240 mg |
| 50 kg and above | 160 mg | Twice daily | 320 mg |
Administration Instructions
Retsevmo tablets can be taken with or without food. However, if you are also taking a proton pump inhibitor (such as omeprazole or lansoprazole), you should take Retsevmo with a full meal to ensure proper absorption.
Swallow the tablet whole with a glass of water. Do not chew, crush, or split the tablets, as this could alter the amount of drug absorbed and affect dosing accuracy.
If you have difficulty swallowing larger tablets, talk to your doctor about taking multiple smaller-strength tablets instead to achieve your prescribed dose.
Adolescents (12 Years and Older)
The same weight-based dosing applies to adolescents aged 12 years and older who are being treated for thyroid cancer or medullary thyroid cancer. Your child’s doctor will determine the appropriate dose based on body weight and will monitor growth and development throughout treatment. If your child experiences hip or knee pain or unexplained limping, inform the doctor promptly, as this may indicate effects on the growth plates.
Dose Adjustments
Your doctor may reduce the dose, temporarily interrupt treatment, or permanently discontinue Retsevmo depending on the type and severity of side effects you experience. Common reasons for dose modification include elevated liver enzymes, significant hypertension, QT prolongation on ECG, or other treatment-related adverse events. It is important to follow your doctor’s instructions regarding dose changes and not to adjust the dose on your own.
Missed Dose
If you miss a dose of Retsevmo, or if you vomit after taking a dose, take the next dose at your regular scheduled time. Do not take a double dose to make up for the missed or vomited dose. Maintaining a consistent dosing schedule helps ensure optimal drug levels and treatment effectiveness.
Overdose
If you have taken too many tablets, or if another person has accidentally taken your medication, contact your doctor or go to a hospital emergency department immediately for advice. Medical treatment may be necessary. Bring the medication packaging with you so that medical staff can identify the drug and the amount taken.
Do not stop taking Retsevmo unless your doctor tells you to do so. Stopping treatment without medical guidance could allow the cancer to progress. If you have questions about your treatment, discuss them with your healthcare team.
What Are the Side Effects of Retsevmo?
The side effects listed below are based on clinical trial data and post-marketing experience. The frequency of side effects is classified according to international convention: very common (affects more than 1 in 10 patients), common (affects 1 in 10 to 1 in 100 patients), uncommon (affects 1 in 100 to 1 in 1,000 patients), and rare (affects fewer than 1 in 1,000 patients).
Stop taking Retsevmo and seek emergency medical help if you notice target-shaped or circular reddish spots on the trunk, skin peeling, blisters, or sores in the mouth, throat, nose, genitals, or eyes, especially if preceded by fever and flu-like symptoms. These may be signs of Stevens-Johnson syndrome (SJS), a serious and potentially life-threatening skin reaction.
Contact your doctor immediately if you experience any of the following:
- Lung or breathing problems: New or worsening shortness of breath, cough, or fever not related to lung cancer (may affect more than 1 in 10 patients)
- Liver problems: Yellowing of skin or eyes, dark urine, nausea, vomiting, loss of appetite, or pain in the upper right abdomen (may affect more than 1 in 10 patients)
- Allergic/hypersensitivity reactions: Fever, muscle and joint pain accompanied by rash (may affect up to 1 in 10 patients)
- High blood pressure: Severe headache, vision changes, chest pain (may affect more than 1 in 10 patients)
- Bleeding: Coughing up blood or any unusual or severe bleeding
Very Common
May affect more than 1 in 10 patients
- Low calcium levels in the blood (hypocalcemia)
- Decreased white blood cells (lymphopenia, neutropenia)
- Low albumin levels in the blood
- Fluid retention causing swollen hands or ankles (edema)
- Diarrhea
- Increased creatinine in the blood (kidney function marker)
- Fatigue or tiredness
- Dry mouth
- Low sodium levels in the blood (hyponatremia)
- Decreased platelets, which may lead to bleeding or bruising (thrombocytopenia)
- Skin rash
- Abdominal pain
- Constipation
- Low hemoglobin levels leading to anemia
- Low magnesium levels in the blood (hypomagnesemia)
- Nausea
- Headache
- Vomiting
- Bleeding symptoms (hemorrhage)
- Erectile dysfunction
- Decreased appetite
- Abnormal ECG (QT prolongation)
- Low potassium levels in the blood (hypokalemia)
- Dizziness
- Urinary tract infection
- Fever
- Inflammation of the mouth lining (stomatitis)
- Decreased thyroid function (hypothyroidism)
Common
May affect 1 in 10 to 1 in 100 patients
- Lymph fluid accumulation in the lung lining or abdominal cavity (pleural/peritoneal effusion), causing breathing difficulties or abdominal swelling
- Irregular growth or damage to the hip joint (slipped capital femoral epiphysis) causing pain or limping in patients under 18 years
Rare but Serious
Uncommon but clinically significant
- Stevens-Johnson syndrome (SJS) – severe skin reaction with blistering and peeling
- Tumor lysis syndrome (TLS) – rapid breakdown of cancer cells causing metabolic imbalance
- Severe hepatotoxicity – serious liver damage
If you experience any side effects, including those not listed above, talk to your doctor, pharmacist, or nurse. Reporting suspected side effects through your national reporting system helps with ongoing monitoring of the benefit-risk balance of medications.
How Should You Store Retsevmo?
Proper storage of Retsevmo is essential to maintain the drug’s effectiveness and safety throughout the treatment period. Follow these storage guidelines carefully:
- Keep out of reach of children: Store this medication where children cannot see or access it. Selpercatinib is a potent anticancer agent and accidental ingestion by children could be extremely dangerous.
- Expiration date: Do not use Retsevmo after the expiration date (EXP) printed on the blister pack and outer carton. The expiration date refers to the last day of the specified month.
- Storage conditions: No special storage conditions are required. Store at room temperature in the original packaging to protect from moisture.
- Packaging integrity: Do not use this medication if the inner seal of the blister pack is broken or shows signs of tampering.
- Disposal: Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures help protect the environment.
If you notice any change in the appearance of the tablets (discoloration, crumbling, unusual odor), do not take them and consult your pharmacist for replacement.
What Does Retsevmo Contain?
Active Ingredient
The active substance is selpercatinib. Each film-coated tablet contains 40 mg, 80 mg, 120 mg, or 160 mg of selpercatinib, depending on the prescribed strength.
Inactive Ingredients
The other ingredients that make up the tablet and its coating are:
- Tablet core: Microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxypropyl cellulose, sodium stearyl fumarate
- Film coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172) [80 mg, 120 mg, 160 mg tablets only], black iron oxide (E172) [40 mg, 80 mg, 120 mg tablets only]
Tablet Appearance
| Strength | Color | Shape | Imprint |
|---|---|---|---|
| 40 mg | Light gray | Round | “5340” / “Ret 40” |
| 80 mg | Dark red-purple | Round | “6082” / “Ret 80” |
| 120 mg | Light purple | Round | “6120” / “Ret 120” |
| 160 mg | Light pink | Round | “5562” / “Ret 160” |
Pack Sizes
Retsevmo is available in blister packs of 30, 56, or 60 film-coated tablets for each strength (40 mg, 80 mg, 120 mg, and 160 mg). Not all pack sizes may be marketed in your country. The marketing authorization holder is Eli Lilly Nederland B.V., Utrecht, the Netherlands, and the manufacturer is Lilly S.A., Alcobendas, Madrid, Spain.
Retsevmo has received a conditional marketing authorization in the European Union. This means that additional evidence about the medicine is expected. The European Medicines Agency reviews new information about this medicine at least annually and updates the product information as needed.
Frequently Asked Questions About Retsevmo
A RET gene alteration is a change in the DNA of the RET gene that causes the RET protein to become permanently active, sending constant growth signals to cells. There are two main types: RET fusions (where the RET gene joins with another gene, creating a fusion protein) and RET point mutations (small changes within the RET gene itself). These alterations drive the uncontrolled growth of cancer cells. Testing your tumor for RET alterations through genetic tests (such as next-generation sequencing) is essential because Retsevmo specifically targets the abnormal RET protein. Without a confirmed RET alteration, the drug would not be expected to be effective against the cancer.
The duration of treatment with Retsevmo varies depending on your individual response and tolerance. In general, treatment continues for as long as the cancer responds to the drug and you are able to tolerate the side effects. Your doctor will perform regular scans and assessments to evaluate whether the cancer is being controlled. Some patients remain on treatment for many months or even years. Never stop taking Retsevmo without consulting your doctor, as abrupt discontinuation may allow the cancer to progress.
Yes, but with important precautions. Acid-reducing medications can affect the absorption of Retsevmo. If you take a proton pump inhibitor (PPI) such as omeprazole or lansoprazole, you must take Retsevmo with a full meal. If you take an H2-receptor blocker such as famotidine or ranitidine, you must take it at least 2 hours after your Retsevmo dose. Always inform your doctor about any acid-reducing medications you are taking so they can provide specific guidance.
If you experience side effects from Retsevmo, contact your healthcare team. Many side effects can be managed effectively with dose adjustments, temporary treatment interruptions, or supportive medications. For serious symptoms such as severe skin reactions (target-shaped rashes, blistering, mouth sores), severe breathing problems, signs of liver damage (jaundice, dark urine), or significant bleeding, seek immediate medical attention. Do not adjust your dose or stop taking the medication without consulting your doctor first.
Retsevmo and Retevmo both contain the same active ingredient, selpercatinib, and are manufactured by Eli Lilly. The name “Retsevmo” is used in the European Union and some other markets, while “Retevmo” is the brand name used in the United States and certain other countries. The drug itself, its mechanism of action, and its clinical efficacy are identical regardless of the brand name used in your region. The available strengths and dosing recommendations are the same.
Yes, Retsevmo is approved for adolescents aged 12 years and older for the treatment of RET-altered thyroid cancer (including medullary thyroid cancer). However, it is not approved for patients under 18 years with lung cancer. The same weight-based dosing applies to adolescents as to adults. Special monitoring for growth and bone development is recommended, as Retsevmo may affect the growth plates, particularly in the hip joint. If your child experiences hip or knee pain or unexplained limping, report it to the doctor immediately.
References
- European Medicines Agency (EMA). Retsevmo (selpercatinib) – Summary of Product Characteristics. Last updated 2026. Available at: EMA – Retsevmo
- U.S. Food and Drug Administration (FDA). Retevmo (selpercatinib) – Prescribing Information. Eli Lilly and Company. Last updated 2025.
- Drilon A, Oxnard GR, Tan DSW, et al. Efficacy of selpercatinib in RET fusion-positive non-small-cell lung cancer. N Engl J Med. 2020;383(9):813-824. doi:10.1056/NEJMoa2005653
- Wirth LJ, Sherman E, Robinson B, et al. Efficacy of selpercatinib in RET-altered thyroid cancers. N Engl J Med. 2020;383(9):825-835. doi:10.1056/NEJMoa2005651
- Solomon BJ, Zhou CC, Drilon A, et al. Phase III study of selpercatinib versus chemotherapy with or without pembrolizumab in untreated RET fusion-positive non-small-cell lung cancer (LIBRETTO-431). J Clin Oncol. 2023;41(26):4194-4205.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 4.2025.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Metastatic Non-Small Cell Lung Cancer. Updated 2025.
- World Health Organization (WHO). Model List of Essential Medicines – 23rd List. 2023.
- Subbiah V, Wolf J, Konda B, et al. Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial. Lancet Oncol. 2022;23(10):1261-1273.
- British National Formulary (BNF). Selpercatinib. National Institute for Health and Care Excellence (NICE). Last updated 2025.
Editorial Team
Medical Content
iMedic Medical Editorial Team – Specialists in Oncology and Clinical Pharmacology
Medical Review
iMedic Medical Review Board – Independent expert panel following EMA, FDA, and NCCN guidelines
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Level 1A – Based on systematic reviews and randomized controlled trials (GRADE framework)
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All medical content is reviewed according to international standards and updated regularly to reflect the latest evidence and regulatory changes. Our editorial team follows the principles of evidence-based medicine and is committed to providing accurate, unbiased, and accessible health information.