Source: Wuxi app rec.
Today, the US FDA announced that it has accelerated the approval of the anti_PD_1 antibody jemperli (dostarlimab) by glaxosmithkline (GSK) to treat patients with relapsed or advanced endometrial cancer. These patients progressed after receiving platinum_containing chemotherapy and carried abnormal characteristics of DNA repair called mismatch repair defects (DMMR). Endometrial cancer is the sixth most common cancer in women worldwide. Approximately 75% of endometrial cencers are diagnosed at an early stage and can usually be cured by sugery. However, women with advanced and recurrent endometrial cencer have limited treatment options after receiving first_line platinum_containing chemotherapy. Approximately 25%_30% of patients with advanced endomatial cencer have dmmr characteristics. Jemperli is a humanized anti_PD_1 monoclonal antibody. It binds to the PD_1 receptor with high affinity, thereby blocking it's binding to PD_L1 and PD_L2 ligands. Relieve PD_1 receptor_mediated immune suppression on T cells and help the human immune system fight cencer. It has obtained the breakthrough designation and priority review qualification granted by the FDA to treat patients with dmmr endometrial cencer.
The safety and effectiveness of jemperli are supported by a single_arm, multi_cohort clinical trial. Among 71 patients with relapsed or advanced endometrial cancer who received jemperli treatment, Jemperli achieved a total remission rate of 42.3% for 93% of remission patients, the duration of remission was more than 6 months.
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