dostarlimab
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The FDA granted accelerated approval to dostarlimab-gxly (Jemperli) for previously untreated stage 2/3 dMMR rectal cancer, based on a 154-patient trial in which about 75% of patients avoided surgery, radiation and chemotherapy within two years of follow-up. An earlier MSKCC study of 50 patients found no evidence of cancer in any of them, and of 27 followed for three years only one relapsed. Patient Jessica Acosta, 29, with a 6 cm tumor, achieved no evidence of disease after treatment. GSK must continue tracking long-term benefit.
Excerpted from medicalxpress.com
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- medicalxpress.comPickNew drug could let some rectal cancer patients skip chemotherapy, radiation and surgery
The FDA granted accelerated approval to dostarlimab-gxly (Jemperli) for previously untreated stage 2/3 dMMR rectal cancer, based on a 154-patient trial in which about 75% of patients avoided surgery, radiation and chemotherapy within two years of follow-up. An earlier MSKCC study of 50 patients found no evidence of cancer in any of them, and of 27 followed for three years only one relapsed. Patient Jessica Acosta, 29, with a 6 cm tumor, achieved no evidence of disease after treatment. GSK must continue tracking long-term benefit.
- biocentury.comGSK’s Jemperli gains rectal cancer approval as rivals advance across colorectal settings
FDA granted accelerated approval to GSK's Jemperli (dostarlimab) for dMMR/MSI-H locally advanced rectal cancer, based on interim results from the Phase II AZUR-1 trial in which nearly three-fourths of patients avoided surgery at a median follow-up of two years. The approval gives Jemperli an indication outside Keytruda's label, and ESMO will present data on other checkpoint inhibitors across lines of colorectal cancer therapy.
- mp.weixin.qq.comFDA Grants Accelerated Approval to GSK's Dostarlimab for Stage II-III MSI-H/dMMR Locally Advanced Rectal Cancer
The FDA has granted accelerated approval to GSK's PD-1 inhibitor dostarlimab (Jemperli) as monotherapy for adult patients with stage II or III MSI-H/dMMR locally advanced rectal cancer. In China, the drug is in phase III trials for colon cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer, and is not yet approved.
- mp.weixin.qq.comGSK dostarlimab wins FDA accelerated approval for MSI-H/dMMR locally advanced rectal cancer
GSK announced on October 19 that dostarlimab has received FDA accelerated approval for adults with stage II and III MSI-H/dMMR locally advanced rectal cancer. The approval is based on single-arm results from the phase 2 AZUR-1 study, in which most patients achieved a sustained complete clinical response.
- mp.weixin.qq.comPickGSK Anti-PD-1 Antibody Dostarlimab Wins FDA Accelerated Approval for Locally Advanced MSI-H/dMMR Rectal Cancer
GSK announced that the FDA has granted accelerated approval to its anti-PD-1 antibody dostarlimab for adults with stage II and III MSI-H/dMMR locally advanced rectal cancer. The company described it as the first immunotherapy approved in the United States for this population. The approval is based on data from the phase 2 AZUR-1 trial. Dostarlimab generated global sales of $1.136 billion in 2025.
- mp.weixin.qq.comFDA Grants Accelerated Approval to Dostarlimab for Organ Preservation in Untreated Stage II/III MSI-H/dMMR Locally Advanced Rectal Cancer
The FDA has granted accelerated approval to dostarlimab for previously untreated stage II/III MSI-H/dMMR locally advanced rectal cancer. Of 154 patients, 110 no longer required surgery, radiotherapy, or chemotherapy. The approval gives some patients who would otherwise need a permanent stoma an option to avoid surgery, radiotherapy, and chemotherapy.
- fda.govFDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
On October 19, the FDA granted accelerated approval to Jemperli (dostarlimab-gxly) as a single agent for adults with previously untreated stage II or stage III locally advanced rectal cancer that is dMMR or MSI-H.
- fda.govPickFDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
On October 19, 2026, the FDA granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with previously untreated, MSI-H or dMMR Stage II/III locally advanced rectal cancer, based on single-arm trial data.
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