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.
Tesaro, a Massachusetts biotech company, developed dostarlimab, one that GlaxoSmithKline purchased in 2019.
WHO MAKES DOSTARLIMAB?
Dostarlimab has been approved by the FDA and EMA for the treatment of adults with dMMR (Mismatch Repair Deficiency) recurrent or advanced endometrial cancer.
It refers to the inability of cells to correct mistakes in DNA replication. Having mismatch repair deficiency can be associated with cells becoming cancerous.
WHAT IS MISMATCH REPAIR DEFICIENCY?
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.
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.
More than 2% of patients experienced serious adverse events, including sepsis, acute kidney injury, urinary tract infection, abdominal pain, and pyrexia.
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.
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