EXPERIMENTAL MEDICATION REVOLUTIONIZES CANCER RESEARCH WITH 100% SUCCESS RATE

WHAT IS DOSTARLIMAB?

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Tesaro, a Massachusetts biotech company, developed dostarlimab, one that GlaxoSmithKline purchased in 2019.

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MEDICAL USES

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It refers to the inability of cells to correct mistakes in DNA replication. Having mismatch repair deficiency can be associated with cells becoming cancerous.

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HISTORY

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TRIALS RESULTS

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More than 2% of patients experienced serious adverse events, including sepsis, acute kidney injury, urinary tract infection, abdominal pain, and pyrexia.

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LEGAL STATUS By EMA

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On April 22, 2021, the Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer

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EXPERIMENTAL MEDICATION REVOLUTIONIZES CANCER RESEARCH WITH 100% SUCCESS RATE

WHAT IS DOSTARLIMAB?

Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody (laboratory-made antibodies design to fight specific illnesses) used as a medication for the treatment of endometrial cancer.

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Tesaro, a Massachusetts biotech company, developed dostarlimab, one that GlaxoSmithKline purchased in 2019.

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WHO MAKES DOSTARLIMAB?

MEDICAL USES

Dostarlimab has been approved by the FDA and EMA for the treatment of adults with dMMR (Mismatch Repair Deficiency) recurrent or advanced endometrial cancer.

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It refers to the inability of cells to correct mistakes in DNA replication. Having mismatch repair deficiency can be associated with cells becoming cancerous.

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WHAT IS MISMATCH REPAIR DEFICIENCY?

HISTORY

Dostarlimab is a PD-1 inhibitor. It is in Phase I/II and Phase III clinical trials as of 2020. The Phase I/II GARNET trial, conducted by the manufacturer Tesaro in 2020, produced promising preliminary results.

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TRIALS RESULTS

In 14 patients with locally advanced stage II/III mismatch repair–deficient rectal cancer, single-agent dostarlimab-gxly elicited a clinical complete response rate of 100% with no evidence of residual tumor.

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More than 2% of patients experienced serious adverse events, including sepsis, acute kidney injury, urinary tract infection, abdominal pain, and pyrexia.

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SIDE EFFECTS

LEGAL STATUS By EMA

On 25 February 2021, the European Medicines Agency (EMA) recommended conditional marketing permission for Jemperli (Dostarlimab), designed to treat recurrent or advanced endometrial cancer.

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On April 22, 2021, the Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer

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LEGAL STATUS By FDA

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