Jemperli FDA Approval History
Last updated by Judith Stewart, BPharm on July 31, 2023.
Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody for the treatment of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer, and dMMR solid tumors.
- Jemperli is indicated for the treatment of:
- in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
- as a single agent for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
- as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Endometrial cancer is a common gynecologic cancer that forms in the endometrium (lining of the uterus). Solid tumors are abnormal masses of tissue devoid of fluids or cysts. In normal cells, mismatch repair (MMR) is a process that corrects errors introduced during DNA replication via enzymes. When the repair mechanism is defective, it is known as mismatch repair-deficient (dMMR), and may lead to an accumulation of errors in the DNA that can cause cancer. Microsatellite instability (MSI) is the condition that results from impaired MMR. MSI-high (MSI-H) means that there is a high amount of instability in a tumor.
- Jemperli contains dostarlimab-gxly which is a programmed death receptor-1 (PD-1)-blocking IgG4 humanized monoclonal antibody. In healthy T-cells, PD-1 acts as a brake that prevents the cells from creating an out-of-control immune response, but in tumors, PD-1 can make T-cells inactive preventing them from killing cancer cells. Jemperli works by binding to the PD-1 receptor on T-cells to block the interaction with the PD-1 ligands PD-L1 and PD-L2, allowing the T-cells to activate and to attack and kill the cancer cells.
- Jemperli is administered as an intravenous infusion over 30 minutes.
- Warnings and precautions associated with Jemperli include immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
- Common adverse reactions when used in combination with carboplatin and paclitaxel in patients with dMMR/MSI-H endometrial cancer include rash, diarrhea, hypothyroidism, and hypertension. Common laboratory abnormalities include decreased neutrophils, decreased hemoglobin, decreased white blood cell count, decreased lymphocytes, increased glucose, decreased sodium, and decreased platelets.
Common adverse reactions when used as a single agent in patients with dMMR solid tumors include fatigue/asthenia, anemia, diarrhea, and nausea. Common laboratory abnormalities include decreased lymphocytes, decreased sodium, increased alkaline phosphatase, and decreased albumin.
Development timeline for Jemperli
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