DOSTARLIMAB
Background and Date of Approval
Dostarlimab is a monoclonal antibody functioning as an immune checkpoint inhibitor that blocks the programmed death receptor-1 (PD-1) pathway. By targeting PD-1, it restores the immune response against tumour cells, enabling the immune system to recognise and destroy cancer cells. The U.S. FDA granted initial approval to Dostarlimab in April 2021 under accelerated approval for treatment of recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer that progressed on or after platinum-based chemotherapy. Full approval was subsequently granted in February 2023 for the same indication. Dostarlimab is undergoing investigation and approval in various countries, including the European Union and India, for extended application in other solid tumours with dMMR.
Uses
Dostarlimab is used in the treatment of: Recurrent or advanced dMMR endometrial cancer in adults whose disease has progressed following platinum-based chemotherapy. dMMR solid tumours (including colorectal, gastric, and ovarian cancers) that have progressed after prior treatment, in patients with no satisfactory alternative therapies. Ongoing clinical studies are exploring its role in combination immunotherapies for other cancers.
Side Effects
Common: Fatigue Nausea, diarrhoea, or constipation Rash or itching Loss of appetite Cough Headache Abdominal pain Serious : Lung inflammation (pneumonitis) – cough, chest pain, shortness of breath Liver problems (hepatitis) – yellowing of eyes/skin, dark urine, severe fatigue Colitis – persistent diarrhoea, bloody stools, severe abdominal pain Kidney problems (nephritis) – reduced urine, swelling in legs, high blood pressure Endocrine disorders – thyroid problems, adrenal insufficiency, diabetes Severe infusion reactions – fever, chills, dizziness, difficulty breathing.
Warnings
Immune-related side effects can affect multiple organs (lungs, liver, colon, kidneys, endocrine glands). May increase the risk of serious infections. Pregnancy/Breastfeeding: May harm an unborn baby or infant. Not recommended. Requires permanent discontinuation if life-threatening immune reactions occur.
Precautions
Contraception: Women should use effective birth control during treatment and for at least 4 months after the last dose. Avoid live vaccines, as the immune system may be suppressed. Monitoring required: Regular blood tests for liver, kidney, thyroid, and hormone levels. Inform your doctor if you have an autoimmune disease, organ transplant history, or prior severe infusion reactions.
References
David O’Malley et al., “Checkpoint inhibition in mismatch repair-deficient tumours: dostarlimab outcomes,” The Lancet Oncology, [2022] https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00299-4/fulltext U.S. FDA, “FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer,” [April 2021] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dostarlimab-gxly-dmmr-endometrial-cancer EMA, “Jemperli (dostarlimab): EPAR – Product Information,” [Accessed Sept 2025] https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli Luis A. Diaz Jr. et al., “Mismatch Repair Deficiency and Response to PD-1 Blockade in Colorectal Cancer,” The New England Journal of Medicine, [2022] https://www.nejm.org/doi/full/10.1056/NEJMoa2201445
Frequently Asked Questions
What cancers is Dostarlimab used for?
It is approved for dMMR/MSI-H endometrial cancer and solid tumours such as colorectal cancer after prior therapy.
What is the method of administering Dostarlimab?
As an IV infusion every 3–6 weeks, depending on the treatment cycle.
Can I take Dostarlimab with chemotherapy?
It may be used alone or in combination with chemotherapy in clinical trials. Your doctor will decide the best approach.
Does Dostarlimab cause hair loss?
Unlike chemotherapy, it usually does not cause major hair loss, though some patients may experience mild thinning.
What is the recommended duration of Dostarlimab therapy?
Treatment duration depends on your response and tolerance. Some patients continue for years if disease control is achieved.