|
GSK PLC on Friday said its drug Jemperli won a regular approval for a form of endometrial cancer and is set to be evaluated for a form of advanced rectal cancer in the US. The Brentford, London-based pharmaceutical company said the US Food & Drug Administration granted regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer. The approval is based on a phase 1 trial with showed an overall response rate of 45%. Hesham Abdullah, senior vice president & global head of oncology development at GSK, said: ‘This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer. We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programmes to address the unmet needs of patients, including earlier lines of endometrial cancer and other solid tumours.’ Further, the FDA’s advisory committee voted in favour of trials designed to evaluate Jemperli as a potential treatment for mismatch repair-deficient/microsatellite instability-high locally advanced rectal cancer. GSK’s Hesham Abdullah said the vote ‘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.’ GSK shares were down 0.4% at 1,497.00 pence each on early Friday morning in London. Copyright 2023 Alliance News Ltd. All Rights Reserved.
|
