Business
Jemperli FDA ODAC positive outcome
Jemperli FDA ODAC positive outcome.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n 9 February 2023, London UK\n \n \n \n \n \n \n \n \n US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli (dostarlimab-gxly) as a potential treatment for mismatch repair-deficient/microsatellite instability-high locally advanced rectal cancer\n \n \n \n \n \n \n \n \n ·\n US FDA also recently granted Fast Track designation to Jemperli in this patient population\n \n \n \n \n \n \n \n \n \n GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 in support of the question posed to the committee regarding whether data from two proposed single-arm trials will be \"sufficient to characterize the benefits and risks\" of Jemperli (dostarlimab-gxly) in the curative-intent setting for patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer.\n \n \n \n \n \n \n Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said:\n \n \"The Committee's positive vote in favour of our proposed clinical trial programme for dostarlimab reinforces our plans to generate data in support of a future US regulatory submission for the potential treatment of patients with dMMR/MSI-H locally advanced rectal cancer, a patient population with significant unmet medical needs and a standard of care that results in serious quality of life concerns. We thank the committee for the constructive dialogue and we look forward to continued interactions with FDA as we progress our development programme.\"\n \n \n \n \n \n The current standard of care (SoC) for patients with dMMR/MSI-H locally advanced rectal cancer is neoadjuvant chemoradiotherapy (CRT) followed by surgery and adjuvant chemotherapy.[i] Neoadjuvant CRT provides local tumour control in most patients, but nearly one-third ultimately die from distant metastasis[ii]. Additionally, SoC is associated with long-term adverse effects, including bowel, urinary and sexual dysfunction, secondary malignancy and infertility i.\n \n \n \n \n \n As part of its proposed clinical trial programme, GSK is initiating a global, open-label, phase II clinical trial to investigate the efficacy and safety of dostarlimab-gxly as monotherapy - as a replacement for chemotherapy, radiation an...