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Jemperli (dostarlimab) plus chemotherapy approved in the US as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Media
Jemperli is the only immuno-oncology treatment approved in a frontline setting for this patient population in combination with chemotherapy
https://www.gsk.com/en-gb/media/press-releases/jemperli-plus-chemotherapy-approved-in-us-for-new-indication/
First published: 31 July 2023
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GSK and Zhifei announce exclusive strategic vaccine partnership in China
Media
Partnership will significantly extend availability of Shingrix in China with co-promotion to healthcare professionals.
https://www.gsk.com/en-gb/media/press-releases/gsk-and-zhifei-announce-exclusive-strategic-vaccine-partnership-in-china/
First published: 09 October 2023
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GSK receives positive CHMP opinion recommending approval of Jemperli (dostarlimab) plus chemotherapy as a new frontline treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Media
Decision on EU marketing authorisation expected by the end of the year.
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-positive-chmp-opinion-recommending-approval-of-jemperli-dostarlimab-plus-chemotherapy/
First published: 16 October 2023
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GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
Media
Decision on EU marketing authorisation expected for momelotinib by early 2024.
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-positive-chmp-opinion-recommending-momelotinib-for-myelofibrosis-patients-with-anaemia/
First published: 13 November 2023
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GSK’s Jemperli (dostarlimab) plus chemotherapy approved as the first and only frontline immuno-oncology treatment in the European Union for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Media
European Commission converts previous conditional approval to full approval as monotherapy for second-line dMMR/MSI-H endometrial cancer.
https://www.gsk.com/en-gb/media/press-releases/jemperli-plus-chemotherapy-approved-as-the-first-and-only-frontline-immuno-oncology-treatment-in-the-european-union/
First published: 11 December 2023
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Jemperli (dostarlimab) plus Zejula (niraparib) combination significantly improved progression-free survival in primary advanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial
Media
Results reinforce development approach of using Jemperli as a backbone in immuno-oncology-based combination therapies
https://www.gsk.com/en-gb/media/press-releases/jemperli-plus-zejula-combination-significantly-improved-progression-free-survival-in-endometrial-cancer-phase-iii-trial/
First published: 18 December 2023
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European Commission authorises GSK’s Omjjara (momelotinib)
Media
First medicine in the EU specifically indicated for splenomegaly or symptoms in adult myelofibrosis patients with moderate to severe anaemia
https://www.gsk.com/en-gb/media/press-releases/european-commission-authorises-gsk-s-omjjara-momelotinib/
First published: 29 January 2024
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Jemperli (dostarlimab) trial continues to show unprecedented results with no evidence of disease in 100% of patients with locally advanced mismatch repair deficient (dMMR) rectal cancer
Media
Updated analysis from Memorial Sloan Kettering Cancer Center presented at ASCO 2024.
https://www.gsk.com/en-gb/media/press-releases/jemperli-dostarlimab-trial-continues-to-show-unprecedented-results/
First published: 03 June 2024
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Jemperli (dostarlimab) plus chemotherapy application accepted for review by the European Medicines Agency to expand use to all patients with primary advanced or recurrent endometrial cancer
Media
Regulatory submission supported by statistically significant and clinically meaningful progression-free and overall survival data
https://www.gsk.com/en-gb/media/press-releases/jemperli-dostarlimab-plus-chemotherapy-application-accepted-for-review-by-ema/
First published: 24 June 2024
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Arexvy, GSK’s Respiratory Syncytial Virus (RSV) vaccine, receives positive European Medicines Agency CHMP opinion for adults aged 50-59 at increased risk for RSV disease
Media
If approved, this will be the first vaccine in the EU for adults aged 50-59 who are at increased risk of RSV disease.
https://www.gsk.com/en-gb/media/press-releases/arexvy-receives-positive-ema-chmp-opinion-for-adults-aged-50-59-at-increased-risk-for-rsv-disease/
First published: 29 July 2024