6 sources • 4 verified points
US FDA approves Jemperli for locally advanced rectal cancer
The US Food and Drug Administration has approved Jemperli (dostarlimab) from GSK for treating adults with locally advanced MSI-H/dMMR rectal cancer, which GSK describes as the first standalone immunotherapy for this group. One source said the approval was accelerated, and another said it is supported by a high complete response rate. The decision matters to patients with this type of cancer.
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- GSK announced that Jemperli received US approval as the first standalone immunotherapy for adults with locally advanced MSI-H/dMMR rectal cancer.
«وافقت الولايات المتحدة على جيمبيرلي كأول علاج مناعي وحيد للبالغين المصابين بسرطان المستقيم المتقدم موضعيا من نوع MSI-H/dMMR»
GSK US - The approval came from the US Food and Drug Administration, according to several sources.
«وافقت إدارة الغذاء والدواء الأمريكية على دواء جيمبرلي لعلاج سرطان المستقيم الموضعي المتقدم المصحوب بنمط dMMR»
Cure Today • Fierce Pharma • The ASCO Post - Fierce Pharma reported that the approval is supported by a high complete response rate.
«نالت جيمبيرلي من GSK موافقة إدارة الغذاء والدواء الأمريكية في سرطان المستقيم، مدعومة بمعدل استجابة كاملة مرتفع»
Fierce Pharma - Pharmaceutical Executive described the approval as accelerated, meaning it is based on early indicators that require follow-up studies later.
«تعني الموافقة المسرّعة أن القرار مبني على مؤشرات مبكرة تستلزم متابعة لاحقة»
Pharmaceutical Executive
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