FDA approved Jemperli (dostarlimab) for dMMR Solid Tumors and Endometrial CancerFDA approved new immunotherapy drug for certain advanced solid tumors

FDA From the archive Source published April 22, 2021 Summary added October 22, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Note: Confirm dMMR status with an FDA-approved test before using single-agent dostarlimab.

The FDA has granted accelerated approval to dostarlimab (Jemperli), a programmed death receptor-1 (PD-1)-blocking antibody, for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors. Eligible patients must have disease that has progressed on or following prior treatment and no satisfactory alternative treatment options. The indication requires confirmation of dMMR status using an FDA-approved test.

This approval provides a targeted immunotherapy option for a biomarker-defined population across solid tumor types. It is based on tumor response rate and durability of response under the accelerated approval pathway; continued approval may depend on verification of clinical benefit in confirmatory trials.

Dostarlimab is also approved as a single agent for dMMR recurrent or advanced endometrial cancer after platinum-based therapy, and in combination with carboplatin and paclitaxel for primary advanced or recurrent endometrial cancer. The recommended dosing for the solid tumor indication is 500 mg every 3 weeks for 4 cycles, then 1000 mg every 6 weeks until progression or unacceptable toxicity.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody. It binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response.

Indication & Patient Population

Dostarlimab is indicated for: - Endometrial cancer: in combination with carboplatin and paclitaxel, followed by dostarlimab as a single agent, for adults with primary advanced or recurrent endometrial cancer. As a single agent, for adults with dMMR recurrent or advanced endometrial cancer that has progressed on or following prior platinum-containing therapy and who are not candidates for curative surgery or radiation. - Mismatch repair deficient (dMMR) recurrent or advanced solid tumors: as a single agent for adults with dMMR recurrent or advanced solid tumors 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.

Patient selection for single-agent therapy requires confirmation of dMMR status in tumor specimens using an FDA-approved test.

Dosing & Administration

- For primary advanced or recurrent endometrial cancer (combination): 500 mg every 3 weeks for 6 cycles in combination with carboplatin and paclitaxel, followed by 1000 mg as monotherapy every 6 weeks for all cycles thereafter. Administer dostarlimab prior to carboplatin and paclitaxel when given on the same day. Continue until disease progression, unacceptable toxicity, or up to 3 years. - For dMMR recurrent or advanced endometrial cancer and dMMR recurrent or advanced solid tumors (monotherapy): 500 mg every 3 weeks for 4 cycles, followed by 1000 mg every 6 weeks for all cycles thereafter. Continue until disease progression or unacceptable toxicity. - Administer as a 30-minute intravenous infusion. - No dose reductions are recommended. Withhold for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions requiring systemic immunosuppression, or inability to reduce corticosteroid dose to 10 mg or less of prednisone equivalent per day within 12 weeks of initiating steroids.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

The label does not provide a full list of warnings and contraindications in the provided text. Please refer to the full prescribing information for complete safety information.

Place in Therapy

Dostarlimab offers a biomarker-directed immunotherapy option for patients with dMMR recurrent or advanced solid tumors who have limited treatment alternatives. It is also approved for dMMR endometrial cancer and in combination with chemotherapy for primary advanced or recurrent endometrial cancer. The accelerated approval for solid tumors requires confirmation of clinical benefit in confirmatory trials.

Jemperli is the brand name for a drug called dostarlimab. It is a type of immunotherapy, which means it helps the body's immune system find and fight cancer cells. The FDA has now approved it for adults with advanced or recurrent solid tumors that have a specific feature called mismatch repair deficiency, or dMMR. This feature can appear in many kinds of cancer, not just one.

The drug is for patients whose cancer has grown after earlier treatment and who have no satisfactory other options. Doctors must confirm the dMMR feature using an FDA-approved test before prescribing it. The approval is based on how well tumors shrank and how long those responses lasted. The FDA calls this accelerated approval, which means the company may need to show more proof of benefit in later studies.

Jemperli was already approved for some endometrial cancers. This new approval expands it to more tumor types with the dMMR feature. It is given by infusion every few weeks.

This is encouraging news for a defined group of patients, but it is not a fit for everyone. If you or someone you know has advanced cancer, talk with your doctor about whether testing and this treatment make sense.

What this means for you:

Jemperli is a new option for some advanced cancers with a specific genetic marker. Ask your doctor if it fits you.

Study Details

Study typeFda approval

PublishedApr 2021

View Original Abstract ↓

1 INDICATIONS AND USAGE JEMPERLI is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Endometrial Cancer • 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 (EC). ( 1.1 ) • as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, 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. ( 1.1 , 2.1 ) Mismatch Repair Deficient Recurrent or Advanced Solid Tumors • 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. 1 ( 1.2 , 2.1 ) 1 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). ( 1.2 ) 1.1 Endometrial Cancer JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC). JEMPERLI, as a single agent, is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, 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 [see Dosage and Administration ( 2.1 )]. 1.2 Mismatch Repair Deficient Recurrent or Advanced Solid Tumors JEMPERLI, as a single agent, is indicated 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 [see Dosage and Administration ( 2.1 )]. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies ( 14.2 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

FDA approved Jemperli (dostarlimab) for dMMR Solid Tumors and Endometrial CancerFDA approved new immunotherapy drug for certain advanced solid tumors

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FDA approved Jemperli (dostarlimab) for dMMR Solid Tumors and Endometrial CancerFDA approved new immunotherapy drug for certain advanced solid tumors

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