Jemperli (Dostarlimab)
PD-1 immune checkpoint inhibitor for the treatment of endometrial cancer. Dostarlimab is a humanized monoclonal antibody that helps the immune system recognize and fight cancer cells.
Jemperli (dostarlimab) is a PD-1 immune checkpoint inhibitor used to treat endometrial cancer (cancer of the uterine lining) in adults. It works by blocking the PD-1 protein on immune cells, allowing the body's own immune system to better detect and destroy cancer cells. Jemperli is administered as an intravenous infusion in a hospital setting and may be given alone or in combination with carboplatin and paclitaxel chemotherapy. As with all immune checkpoint inhibitors, Jemperli can cause immune-mediated adverse reactions that require careful monitoring.
Quick Facts
Key Takeaways
- Jemperli (dostarlimab) is a PD-1 immune checkpoint inhibitor approved for the treatment of endometrial cancer in adults, particularly in cases with mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H).
- It is administered as an intravenous infusion over 30 minutes in a hospital or clinical setting, either as monotherapy or in combination with carboplatin and paclitaxel chemotherapy.
- Jemperli can cause potentially life-threatening immune-mediated adverse reactions affecting the lungs, liver, intestines, kidneys, hormone glands, skin, heart, and nervous system, which require immediate medical attention.
- Women of childbearing potential must use effective contraception during treatment and for at least 4 months after the last dose, as the drug may cause fetal harm.
- Regular blood tests and medical monitoring are essential throughout treatment to detect and manage immune-related side effects as early as possible.
What Is Jemperli (Dostarlimab) and What Is It Used For?
Jemperli (dostarlimab) is a humanized monoclonal antibody that targets the PD-1 receptor on immune cells. It is used to treat endometrial cancer in adults, either as a single agent or in combination with chemotherapy, by enabling the immune system to recognize and attack cancer cells more effectively.
Jemperli belongs to a class of drugs known as immune checkpoint inhibitors. These medications work by interfering with the mechanisms that cancer cells use to evade the immune system. Under normal circumstances, immune cells called T cells patrol the body looking for abnormal cells, including cancer cells. However, cancer cells can exploit a natural "brake" on the immune system called the PD-1/PD-L1 pathway to avoid being detected and destroyed.
The active ingredient, dostarlimab, is a humanized monoclonal antibody specifically designed to bind to the PD-1 (programmed death-1) receptor found on the surface of T cells. By blocking this receptor, dostarlimab prevents cancer cells from sending "stop" signals to T cells through PD-L1 and PD-L2 ligands. This releases the natural braking mechanism and allows T cells to mount a more effective immune response against the tumour.
Jemperli is specifically approved for the treatment of endometrial cancer (also known as uterine corpus cancer or cancer of the uterine lining) in adult patients. Endometrial cancer is one of the most common gynaecological cancers worldwide, and its incidence has been increasing in recent decades. Jemperli addresses a significant unmet need in this disease area, particularly for patients whose tumours exhibit specific molecular features.
Approved Indications
Jemperli is authorized for use in the following clinical settings:
- First-line treatment in combination with chemotherapy: For adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), in combination with carboplatin and paclitaxel chemotherapy.
- Monotherapy for previously treated cancer: For adult patients with dMMR/MSI-H endometrial cancer that has progressed on or after a prior platinum-containing chemotherapy regimen, and who are not candidates for curative surgery or radiation.
Understanding dMMR and MSI-H
The terms dMMR (mismatch repair deficient) and MSI-H (microsatellite instability-high) refer to specific molecular features of a tumour. Mismatch repair (MMR) is a cellular mechanism responsible for correcting errors that occur during DNA replication. When this system is deficient (dMMR), the tumour accumulates many genetic mutations, leading to microsatellite instability (MSI-H). Tumours with these features tend to produce more abnormal proteins (neoantigens) that the immune system can potentially recognize, making them particularly responsive to immune checkpoint inhibitor therapy like Jemperli.
Testing for dMMR/MSI-H status is performed on a tumour tissue sample and is essential before starting treatment with Jemperli. This testing may be done using immunohistochemistry (IHC) to assess MMR protein expression, or polymerase chain reaction (PCR) or next-generation sequencing (NGS) to assess MSI status. Your oncologist will arrange this testing as part of the diagnostic workup.
How Jemperli Differs from Chemotherapy
Unlike traditional chemotherapy, which directly kills rapidly dividing cells (both cancerous and healthy), Jemperli works by harnessing the patient's own immune system to fight cancer. This fundamentally different mechanism of action means that the side effect profile is distinct from chemotherapy. Rather than causing hair loss, severe nausea, or bone marrow suppression typical of chemotherapy, Jemperli's side effects are predominantly immune-related, resulting from an overactive immune system that may attack healthy tissues in addition to cancer cells.
Clinical Trial Evidence
The approval of Jemperli was supported by the RUBY trial (also known as ENGOT-EN6-NSGO/GOG-3031), a pivotal phase III clinical trial that demonstrated significant improvements in progression-free survival for patients with dMMR/MSI-H endometrial cancer treated with Jemperli plus chemotherapy compared to chemotherapy alone. In the dMMR/MSI-H population, the combination of Jemperli with carboplatin and paclitaxel reduced the risk of disease progression or death by approximately 72% compared to placebo plus chemotherapy.
What Should You Know Before Receiving Jemperli?
Before starting Jemperli, your oncologist will assess your overall health, review your medical history, and test your tumour for dMMR/MSI-H status. Certain medical conditions, medications, and life circumstances (such as pregnancy) require special consideration or may preclude treatment.
Contraindications
You should not receive Jemperli if you have a known allergy (hypersensitivity) to dostarlimab or any of the other ingredients in the formulation, including trisodium citrate dihydrate, citric acid monohydrate, L-arginine hydrochloride, sodium chloride, polysorbat 80, and water for injections. Allergic reactions to the infusion can range from mild skin reactions to severe anaphylaxis.
Warnings and Precautions
Before receiving Jemperli, it is essential to inform your doctor or nurse about all aspects of your medical history. This is particularly important if you have any of the following conditions:
- Autoimmune disorders: If you have an autoimmune condition such as lupus, rheumatoid arthritis, inflammatory bowel disease, or multiple sclerosis, Jemperli may worsen your condition. Immune checkpoint inhibitors can exacerbate existing autoimmune diseases or trigger new autoimmune reactions.
- Lung or breathing problems: Pre-existing lung conditions such as chronic obstructive pulmonary disease (COPD), asthma, or interstitial lung disease may increase the risk of immune-mediated pneumonitis.
- Liver or kidney problems: Impaired liver or kidney function may affect how your body handles the drug and may increase susceptibility to certain immune-mediated adverse reactions.
- Previous organ transplant: Jemperli may cause organ transplant rejection by activating the immune system. Patients who have received solid organ transplants or bone marrow (stem cell) transplants are at particular risk for graft rejection or graft-versus-host disease (GvHD).
- Severe skin conditions: A history of serious skin reactions, including Stevens-Johnson syndrome or toxic epidermal necrolysis, requires careful consideration before starting immunotherapy.
Important Safety Warning
Jemperli can cause serious immune-mediated adverse reactions that may be life-threatening and can lead to death. These reactions can occur at any time during treatment or even after treatment has been completed. You may experience more than one adverse reaction simultaneously. Report any new or worsening symptoms to your healthcare team immediately.
Drug Interactions
Inform your doctor about all medications you are currently taking, have recently taken, or plan to take. Certain medications can affect how Jemperli works or increase the risk of adverse effects:
- Immunosuppressive medications: Drugs that suppress the immune system, such as corticosteroids (e.g., prednisone, dexamethasone), may reduce the effectiveness of Jemperli. However, your doctor may prescribe corticosteroids to manage immune-related side effects once they occur.
- Other immunomodulating therapies: Other medications that modify the immune response should be discussed with your oncologist, as they may interact with the mechanism of action of dostarlimab.
It is important to note that while Jemperli is often given in combination with carboplatin and paclitaxel, these chemotherapy agents have their own set of drug interactions and side effects. Refer to the prescribing information for those medications as well.
Pregnancy and Breastfeeding
Jemperli may cause significant harm to an unborn baby. Based on its mechanism of action, blocking PD-1 signalling may disrupt normal immune tolerance during pregnancy, potentially leading to fetal harm or fetal death. Therefore:
- Pregnancy: You must not receive Jemperli if you are pregnant unless your oncologist specifically advises it after careful consideration of the risks and benefits. If you are of childbearing potential, a pregnancy test should be performed before starting treatment.
- Contraception: Women of childbearing potential must use effective contraception during treatment with Jemperli and for at least 4 months after the last dose.
- Breastfeeding: It is not known whether dostarlimab passes into breast milk. Because of the potential for serious adverse reactions in the nursing infant, breastfeeding must be avoided during treatment and for at least 4 months after the last dose.
- Fertility: The effects of dostarlimab on human fertility have not been studied. Discuss fertility preservation options with your oncologist before starting treatment if relevant to your situation.
Children and Adolescents
Jemperli is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of dostarlimab in paediatric patients have not been established.
Driving and Operating Machinery
Jemperli is unlikely to directly affect your ability to drive or operate machinery. However, if you experience side effects such as fatigue, dizziness, or difficulty concentrating, you should exercise caution when driving or operating machinery until you know how the treatment affects you.
Excipient Information
Jemperli contains polysorbat 80 (2 mg per dose unit), which may cause allergic reactions in some individuals. Inform your doctor if you have any known allergies to polysorbat. The medicine also contains less than 1 mmol sodium (23 mg) per dose and is therefore essentially sodium-free. However, before administration, Jemperli is diluted with a solution that may contain sodium. If you are on a low-sodium diet, discuss this with your healthcare provider.
How Does Jemperli Interact with Other Drugs?
Jemperli's primary drug interactions involve immunosuppressive agents such as corticosteroids, which may diminish its anti-cancer effects. As a monoclonal antibody, dostarlimab is not metabolized by liver enzymes, so traditional pharmacokinetic drug interactions are limited.
Unlike many conventional medications that are processed by liver enzymes (cytochrome P450 system), monoclonal antibodies such as dostarlimab are broken down through proteolytic degradation. This means that Jemperli has a relatively low risk of traditional pharmacokinetic drug interactions. However, pharmacodynamic interactions related to its immune-modulating mechanism of action are clinically significant.
Major Interactions
| Drug/Class | Interaction Type | Clinical Significance |
|---|---|---|
| Systemic corticosteroids (prednisone, dexamethasone) | Pharmacodynamic – immunosuppression | May reduce the efficacy of Jemperli by suppressing T-cell activation. Avoid chronic use before and during Jemperli treatment; however, corticosteroids are used to manage immune-related adverse events. |
| Other immunosuppressants (azathioprine, mycophenolate, cyclosporine, tacrolimus) | Pharmacodynamic – immunosuppression | Significant reduction in anti-tumour immune response. Use with extreme caution; may negate the therapeutic benefit of Jemperli. |
| Live vaccines | Pharmacodynamic – immune modulation | The altered immune response during Jemperli treatment may lead to unpredictable responses to live vaccines. Live vaccines should generally be avoided during immunotherapy. |
Combination Chemotherapy Interactions
When Jemperli is administered in combination with carboplatin and paclitaxel, additional drug interactions from the chemotherapy agents must be considered. Carboplatin is nephrotoxic and ototoxic, and paclitaxel is metabolized by CYP2C8 and CYP3A4 enzymes. Inhibitors or inducers of these enzymes may affect paclitaxel levels. Your oncologist will manage these potential interactions as part of your overall treatment plan.
Minor Interactions
There are no well-documented clinically significant minor pharmacokinetic interactions with dostarlimab specifically, as the drug is cleared through proteolytic pathways rather than hepatic metabolism. However, patients receiving Jemperli are often on multiple medications, and comprehensive medication review is recommended before each treatment cycle.
Important Note
Always inform your oncologist and pharmacist about all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. While dostarlimab itself has limited pharmacokinetic interactions, the overall treatment context may involve drugs with significant interaction profiles.
What Is the Correct Dosage of Jemperli?
Jemperli is administered as a 30-minute intravenous infusion. As monotherapy, the dose is 500 mg every 3 weeks for 4 doses, then 1,000 mg every 6 weeks. In combination with chemotherapy, 500 mg every 3 weeks for 6 doses, then 1,000 mg every 6 weeks.
Jemperli is always administered in a hospital or clinical setting under the supervision of a physician experienced in cancer treatment. The dosing schedule depends on whether the drug is being used as a single agent (monotherapy) or in combination with chemotherapy.
Adults – Monotherapy
Monotherapy Dosing Schedule
When Jemperli is used alone (as monotherapy) for previously treated dMMR/MSI-H endometrial cancer:
- Loading phase (Doses 1–4): 500 mg administered by intravenous infusion every 3 weeks
- Maintenance phase (Dose 5 onwards): 1,000 mg administered by intravenous infusion every 6 weeks
Each infusion is given over approximately 30 minutes. Treatment continues until disease progression, unacceptable toxicity, or for the duration determined by your oncologist.
Adults – Combination with Chemotherapy
Combination Dosing Schedule (with Carboplatin and Paclitaxel)
When Jemperli is used in combination with carboplatin and paclitaxel for first-line treatment of advanced or recurrent dMMR/MSI-H endometrial cancer:
- Loading phase (Doses 1–6): 500 mg administered by intravenous infusion every 3 weeks, alongside chemotherapy
- Maintenance phase (Dose 7 onwards): 1,000 mg administered by intravenous infusion every 6 weeks, after completion of chemotherapy
Chemotherapy (carboplatin and paclitaxel) is typically given for 6 cycles, after which Jemperli continues as single-agent maintenance therapy.
Dosage Adjustment Table
| Regimen | Loading Phase | Maintenance Phase | Infusion Duration |
|---|---|---|---|
| Monotherapy | 500 mg every 3 weeks × 4 doses | 1,000 mg every 6 weeks | ~30 minutes |
| Combination therapy | 500 mg every 3 weeks × 6 doses | 1,000 mg every 6 weeks | ~30 minutes |
Children and Adolescents
Jemperli is not approved for use in patients under 18 years of age. There is no established paediatric dosing for dostarlimab.
Elderly Patients
No dose adjustment is required for elderly patients. Clinical trials included patients over 65 years of age, and no overall differences in safety or efficacy were observed between older and younger patients. However, elderly patients may be more susceptible to certain immune-mediated adverse reactions, and close monitoring is recommended.
Renal and Hepatic Impairment
No dose adjustment is required for patients with mild to moderate renal impairment or mild hepatic impairment. Jemperli has not been specifically studied in patients with severe renal impairment, severe hepatic impairment, or end-stage renal disease. Decisions about dosing in these populations should be made by the treating oncologist on a case-by-case basis.
Missed Dose
If you miss a scheduled appointment for your Jemperli infusion, contact your doctor or hospital immediately to reschedule. It is very important that you do not miss a dose of this medication. Your doctor will arrange a new appointment as soon as possible and may adjust the subsequent dosing schedule accordingly.
Overdose
Because Jemperli is administered by healthcare professionals in a controlled clinical setting, overdose is unlikely. In the event of an overdose, the patient would be closely monitored for signs and symptoms of adverse reactions, and appropriate supportive treatment would be initiated. There is no specific antidote for dostarlimab overdose.
Dose Modifications for Adverse Reactions
Dose reductions of Jemperli are not recommended. Instead, treatment may be withheld (temporarily suspended) or permanently discontinued depending on the type and severity of immune-mediated adverse reactions. Your oncologist will use established grading criteria (Common Terminology Criteria for Adverse Events, CTCAE) to guide dose modification decisions. In general:
- Grade 2 immune-mediated reactions: Treatment may be withheld until symptoms resolve to Grade 0–1 with or without corticosteroid therapy.
- Grade 3 immune-mediated reactions: Treatment is typically withheld. High-dose corticosteroids are initiated. Jemperli may be resumed once symptoms improve to Grade 0–1 and corticosteroids are tapered.
- Grade 4 immune-mediated reactions: Treatment is permanently discontinued, except for certain endocrinopathies that can be managed with hormone replacement therapy.
What Are the Side Effects of Jemperli?
Like all immune checkpoint inhibitors, Jemperli can cause immune-mediated side effects where the activated immune system attacks healthy tissues. Common side effects include anaemia, hypothyroidism, diarrhoea, nausea, rash, joint pain, and fever. Serious immune-mediated adverse reactions affecting the lungs, liver, intestines, kidneys, and other organs can also occur.
The side effect profile of Jemperli is characteristic of anti-PD-1 immunotherapy. While many patients tolerate the treatment well, the reactivated immune system may inadvertently attack healthy organs and tissues, leading to immune-mediated adverse reactions. These can range from mild and manageable to severe and potentially life-threatening. Early recognition and prompt treatment of these reactions are critical to patient safety.
Immune-Mediated Adverse Reactions
The following table summarizes the most important immune-mediated adverse reactions that can occur with Jemperli. These reactions can develop at any point during treatment or even after treatment has ended. Report any new symptoms to your healthcare team immediately.
| Condition | Possible Symptoms |
|---|---|
| Pneumonitis (lung inflammation) | Shortness of breath, chest pain, new or worsening cough |
| Colitis/Enteritis (intestinal inflammation) | Diarrhoea, bloody or mucous stools, severe abdominal pain, nausea, vomiting |
| Hepatitis (liver inflammation) | Nausea, loss of appetite, right-sided abdominal pain, jaundice (yellowing of skin/eyes), dark urine, easy bruising |
| Endocrinopathies (hormone gland disorders) | Palpitations, weight changes, increased sweating, hair loss, feeling cold, constipation, dizziness, fatigue, headache |
| Type 1 Diabetes (including diabetic ketoacidosis) | Increased hunger/thirst, frequent urination, weight loss, nausea, fruity-smelling breath, rapid breathing |
| Nephritis (kidney inflammation) | Changes in urine amount or colour, swollen ankles, loss of appetite, blood in urine |
| Skin reactions | Rash, itching, dry or peeling skin, skin ulcers, sores in mouth/nose/throat/genital area |
| Myocarditis (heart muscle inflammation) | Breathing difficulties, dizziness, fever, chest pain, flu-like symptoms |
| Neurological reactions (encephalitis, Guillain-Barré syndrome, myasthenia gravis) | Stiff neck, headache, fever, confusion, muscle weakness, numbness/tingling, difficulty swallowing or speaking, vision changes |
| Myelitis (spinal cord inflammation) | Pain, numbness, tingling or weakness in arms/legs, bladder or bowel problems |
Side Effects When Used as Monotherapy
The following side effects have been reported in clinical trials when Jemperli was used as a single agent:
Very Common
May affect more than 1 in 10 people
- Anaemia (decreased red blood cells)
- Hypothyroidism (underactive thyroid)
- Diarrhoea
- Nausea
- Vomiting
- Skin redness or rash
- Blistering of skin or mucous membranes
- Itching (pruritus)
- Joint pain (arthralgia)
- Fever (pyrexia)
- Elevated liver enzymes
Common
May affect up to 1 in 10 people
- Hyperthyroidism (overactive thyroid)
- Adrenal insufficiency
- Pneumonitis (lung inflammation)
- Colitis (colon inflammation)
- Pancreatitis (pancreas inflammation)
- Gastritis (stomach inflammation)
- Hepatitis (liver inflammation)
- Muscle pain (myalgia)
- Chills
- Infusion-related reactions
- Hypersensitivity reactions
Uncommon
May affect up to 1 in 100 people
- Encephalitis (brain inflammation)
- Autoimmune haemolytic anaemia
- Hypophysitis (pituitary gland inflammation)
- Thyroiditis (thyroid inflammation)
- Type 1 diabetes or diabetic ketoacidosis
- Oesophagitis (oesophageal inflammation)
- Myasthenia gravis
- Arthritis (joint inflammation)
- Myositis (muscle inflammation)
- Uveitis/Iritis (eye inflammation)
- Nephritis (kidney inflammation)
Reported (Frequency Unknown)
Reported in an unknown number of patients
- Coeliac disease (gluten intolerance)
- Exocrine pancreatic insufficiency
Side Effects When Used with Chemotherapy
When Jemperli is administered in combination with carboplatin and paclitaxel, the following side effects have been observed:
Very Common
May affect more than 1 in 10 people
- Hypothyroidism (underactive thyroid)
- Skin rash
- Dry skin
- Fever (pyrexia)
- Elevated liver enzymes
Common
May affect up to 1 in 10 people
- Hyperthyroidism (overactive thyroid)
- Pneumonitis (lung inflammation)
- Colitis (colon inflammation)
- Pancreatitis (pancreas inflammation)
Uncommon
May affect up to 1 in 100 people
- Thyroiditis (thyroid inflammation)
- Adrenal insufficiency
- Type 1 diabetes
- Myasthenic syndrome
- Guillain-Barré syndrome
- Myocarditis (heart muscle inflammation)
- Gastritis (stomach inflammation)
- Gastrointestinal vasculitis
- Uveitis (eye inflammation)
- Arthritis (joint inflammation)
- Myositis (muscle inflammation)
- Systemic inflammatory reaction
Reported (Frequency Unknown)
Reported in an unknown number of patients
- Coeliac disease (gluten intolerance)
- Exocrine pancreatic insufficiency
Infusion-Related Reactions
Some patients may experience allergic-type reactions during or shortly after the intravenous infusion of Jemperli. These reactions typically occur within minutes to hours of the infusion but can develop up to 24 hours later. Symptoms may include:
- Shortness of breath or wheezing
- Itching or rash
- Flushing (skin redness)
- Dizziness
- Chills or shaking
- Fever
- Low blood pressure (feeling faint)
Seek immediate medical attention if you experience any signs of an infusion reaction. Your healthcare team is trained to manage these reactions and will monitor you during and after each infusion.
Transplant-Related Complications
In patients who have received an allogeneic stem cell (bone marrow) transplant, Jemperli may cause transplant rejection or graft-versus-host disease (GvHD). These complications can be serious and potentially fatal. They may occur whether the transplant was performed before or after treatment with Jemperli. Your doctor will monitor you closely for signs of these complications.
When to Seek Immediate Medical Attention
Contact your healthcare team immediately or go to the nearest emergency department if you experience: severe or persistent diarrhoea, shortness of breath, chest pain, yellowing of skin or eyes, severe rash or skin blistering, sudden confusion, muscle weakness, severe headache with fever, or any symptoms that concern you. Early intervention for immune-mediated reactions significantly improves outcomes.
How Should Jemperli Be Stored?
Jemperli is stored and handled by healthcare professionals at your hospital or clinic. The concentrate must be refrigerated at 2–8°C, protected from light, and must not be frozen. Once diluted, it can be stored for up to 24 hours refrigerated or 6 hours at room temperature.
As Jemperli is administered exclusively in a hospital or clinical setting, you will not need to store the medication at home. However, understanding the storage requirements can provide useful context about the medication's handling:
- Storage temperature: The undiluted concentrate must be stored in a refrigerator at 2–8°C (36–46°F).
- Freezing: Jemperli must not be frozen. If accidentally frozen, the product should be discarded.
- Light protection: The product must be stored in its original packaging to protect it from light.
- Shelf life: Use before the expiry date printed on the carton and vial after "EXP." The expiry date refers to the last day of the stated month.
- After dilution: Once diluted for infusion, the solution can be stored for up to 24 hours at 2–8°C, or up to 6 hours at room temperature (up to 25°C), from the time of preparation to the end of administration.
- Visual inspection: The prepared solution should not be used if it contains visible particles. Healthcare staff will inspect the solution before administering it.
Keep all medicines out of the sight and reach of children. Do not use this medicine after the expiry date. Any unused product or waste material should be disposed of in accordance with local requirements.
What Does Jemperli Contain?
Each vial of Jemperli contains 500 mg of dostarlimab in 10 mL of concentrate (50 mg/mL). Inactive ingredients include trisodium citrate dihydrate, citric acid monohydrate, L-arginine hydrochloride, sodium chloride, polysorbat 80, and water for injections.
Active Ingredient
The active substance is dostarlimab. Each glass vial contains 500 mg of dostarlimab in 10 mL of concentrate for solution for infusion (sterile concentrate), providing a concentration of 50 mg/mL.
Inactive Ingredients (Excipients)
- Trisodium citrate dihydrate (E331) – buffer to maintain pH
- Citric acid monohydrate (E330) – buffer to maintain pH
- L-arginine hydrochloride – stabilizer
- Sodium chloride – tonicity agent
- Polysorbat 80 (E433) – surfactant to prevent protein aggregation
- Water for injections – solvent
Appearance and Packaging
Jemperli is a clear to slightly opalescent, colourless to yellow solution that is essentially free from visible particles. The product is supplied in cartons containing one glass vial.
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
Frequently Asked Questions About Jemperli
Medical References and Sources
This article is based on current medical research, regulatory documents, and international clinical guidelines. All claims are supported by scientific evidence from peer-reviewed sources.
- Mirza MR, Chase DM, Slomovitz BM, et al. (2023). "Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer." New England Journal of Medicine, 388(23):2145-2158. https://doi.org/10.1056/NEJMoa2216334 Pivotal RUBY phase III trial demonstrating significant PFS improvement with dostarlimab in dMMR/MSI-H endometrial cancer. Evidence level: 1B
- European Medicines Agency (2024). "Jemperli (dostarlimab) – Summary of Product Characteristics." EMA EPAR: Jemperli Official European regulatory product information including approved indications, dosing, and safety data. Evidence level: Regulatory
- U.S. Food and Drug Administration (2023). "FDA Label: Jemperli (dostarlimab-gxly) for injection." FDA Prescribing Information US regulatory prescribing information with comprehensive safety and efficacy data. Evidence level: Regulatory
- Colombo N, Creutzberg C, Amant F, et al. (2024). "ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up of endometrial cancer." Annals of Oncology. https://doi.org/10.1016/j.annonc.2024.01.001 European Society for Medical Oncology guidelines on endometrial cancer management including immunotherapy recommendations. Evidence level: 1A
- National Comprehensive Cancer Network (2024). "NCCN Clinical Practice Guidelines in Oncology: Uterine Neoplasms." Version 1.2024. NCCN Guidelines US consensus guidelines for uterine cancer treatment including immune checkpoint inhibitor recommendations. Evidence level: 1A
- Oaknin A, Gilbert L, Tinker AV, et al. (2023). "Safety and antitumor activity of dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) or proficient/stable (MMRp/MSS) endometrial cancer: updated results from GARNET." Journal of Clinical Oncology, 41(suppl): abstract 5524. https://doi.org/10.1200/JCO.2023.41.16_suppl.5524 Updated GARNET trial data demonstrating durable responses with dostarlimab in dMMR/MSI-H endometrial cancer. Evidence level: 2B
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Evidence level 1A represents the highest quality of evidence, based on systematic reviews of randomized controlled trials. Regulatory sources (EMA, FDA) represent official product information reviewed by regulatory authorities.
iMedic Editorial Standards
Peer Review Process
All pharmaceutical content is reviewed by at least two independent specialist physicians before publication, with additional review by a clinical pharmacologist.
Fact-Checking
Every medical claim is verified against primary sources: regulatory documents (EMA SmPC, FDA labels), peer-reviewed clinical trials, and international guidelines (ESMO, NCCN).
Update Frequency
Articles are reviewed every 6 months or when significant new data becomes available, such as updated regulatory approvals, new clinical trial results, or guideline changes.
Corrections Policy
Errors are corrected promptly with full transparency. Major corrections are documented with date and description of the change at the bottom of the article.
Medical Editorial Board: Our content undergoes rigorous multi-stage review. Learn more about our medical team and editorial standards.