GSK: thumbs up from CHMP for dostarlimab
(CercleFinance.com) - GSK has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending approval of Jemperli (dostarlimab), in combination with chemotherapy, as a new first-line treatment for dMMR/MSI-H advanced or recurrent primary endometrial cancer.
The CHMP opinion is one of the final steps prior to a marketing authorization decision by the European Commission.
GSK's application for dostarlimab is based on the interim analysis results from part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial, which were presented at the European Society for Medical Oncology (ESMO) meeting and the Society of Gynecological Oncology (SGO) annual meeting on 27 March 2023.
In the dMMR/MSI-H population, a 72% reduction in the risk of disease progression or death was observed.
In a prespecified exploratory analysis of overall survival (OS) in the dMMR/MSI-H population, the addition of dostarlimab to chemotherapy resulted in a 70% reduction in the risk of death compared with chemotherapy alone.
Copyright (c) 2023 CercleFinance.com. All rights reserved.
The CHMP opinion is one of the final steps prior to a marketing authorization decision by the European Commission.
GSK's application for dostarlimab is based on the interim analysis results from part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial, which were presented at the European Society for Medical Oncology (ESMO) meeting and the Society of Gynecological Oncology (SGO) annual meeting on 27 March 2023.
In the dMMR/MSI-H population, a 72% reduction in the risk of disease progression or death was observed.
In a prespecified exploratory analysis of overall survival (OS) in the dMMR/MSI-H population, the addition of dostarlimab to chemotherapy resulted in a 70% reduction in the risk of death compared with chemotherapy alone.
Copyright (c) 2023 CercleFinance.com. All rights reserved.