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Dostarlimab
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Dostarlimab
Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody used as an anti-cancer medication for the treatment of endometrial cancer. Dostarlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.
The most common side effects reported in the US include fatigue/asthenia, nausea, diarrhea, anemia, and constipation. Additional side effects reported in the European Union include vomiting, joint pain, itching, rash, fever, and hypothyroidism (low levels of thyroid hormones).
Dostarlimab was approved for the treatment of endometrial cancer in both the United States and the European Union in April 2021.
Based on the Garnet trial, dostarlimab gained accelerated approval from the US Food and Drug Administration (FDA) in April 2021, and full approval in February 2023.
Dostarlimab has been approved to treat specific cancers in various jurisdictions.
In endometrial cancer cancerous cells reside in the lining of the uterus (endometrium). The four stages in endometrial cancer range from settling in the endometrium to metastasizing to other organs. This disease can be treated if discovered early enough. Studies report that chemoresistant MSI-high tumors can be treated with dostarlimab and pembrolizumab.
In the European Union, dostarlimab is indicated as monotherapy for the treatment of adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-based regimen such as cisplatin, carboplatin or oxaliplatin.
Dostarlimab is approved in the US for adults with dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment and who lack satisfactory alternative treatment options. Dostarlimab, in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab, is approved for primary advanced or recurrent dMMR endometrial cancer. Efficacy was evaluated in RUBY (NCT03981796), a randomized, multicenter, double-blind, placebo-controlled trial. Efficacy was assessed in a pre-specified subgroup of 122 participants with dMMR/MSI-H primary advanced or recurrent endometrial cancer. MMR/MSI tumor status was assessed by local testing assays (IHC, PCR, or NGS), or central testing (IHC), using the Ventana MMR RxDx Panel, when local results were unavailable. In August 2024, the Food and Drug Administration approved dostarlimab with carboplatin and paclitaxel, followed by single-agent dostarlimab, for adults with primary advanced or recurrent endometrial cancer. Dostarlimab previously was approved with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).
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Dostarlimab
Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody used as an anti-cancer medication for the treatment of endometrial cancer. Dostarlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.
The most common side effects reported in the US include fatigue/asthenia, nausea, diarrhea, anemia, and constipation. Additional side effects reported in the European Union include vomiting, joint pain, itching, rash, fever, and hypothyroidism (low levels of thyroid hormones).
Dostarlimab was approved for the treatment of endometrial cancer in both the United States and the European Union in April 2021.
Based on the Garnet trial, dostarlimab gained accelerated approval from the US Food and Drug Administration (FDA) in April 2021, and full approval in February 2023.
Dostarlimab has been approved to treat specific cancers in various jurisdictions.
In endometrial cancer cancerous cells reside in the lining of the uterus (endometrium). The four stages in endometrial cancer range from settling in the endometrium to metastasizing to other organs. This disease can be treated if discovered early enough. Studies report that chemoresistant MSI-high tumors can be treated with dostarlimab and pembrolizumab.
In the European Union, dostarlimab is indicated as monotherapy for the treatment of adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-based regimen such as cisplatin, carboplatin or oxaliplatin.
Dostarlimab is approved in the US for adults with dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment and who lack satisfactory alternative treatment options. Dostarlimab, in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab, is approved for primary advanced or recurrent dMMR endometrial cancer. Efficacy was evaluated in RUBY (NCT03981796), a randomized, multicenter, double-blind, placebo-controlled trial. Efficacy was assessed in a pre-specified subgroup of 122 participants with dMMR/MSI-H primary advanced or recurrent endometrial cancer. MMR/MSI tumor status was assessed by local testing assays (IHC, PCR, or NGS), or central testing (IHC), using the Ventana MMR RxDx Panel, when local results were unavailable. In August 2024, the Food and Drug Administration approved dostarlimab with carboplatin and paclitaxel, followed by single-agent dostarlimab, for adults with primary advanced or recurrent endometrial cancer. Dostarlimab previously was approved with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).