GSK’s Jemperli (dostarlimab) Secures the US FDA’s Breakthrough Therapy Designation to Treat Rectal Cancer
Shots:
- The US FDA has granted BTD to Jemperli for treating locally advanced dMMR)/MSI-H rectal cancer
- Designation was based on P-II study (conducted with Memorial Sloan Kettering Cancer Center) in dMMR rectal cancer patients (n=42), showing a 100% clinical CR in all, without any evidence of tumors on MRI, endoscopy, PET scan, or digital rectal exam
- Furthermore, sustained cCR was observed at a median follow-up of 26.3mos. in first 24 of them and is underway to assess the patients; safety profile aligned with known data without grade 3+ AEs. GSK’s registrational P-II (AZUR-1) trial is ongoing to validate this data
Ref: GSK | Image: GSK
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.