Mohit Manrao: FDA Grants Priority Review for sBLA in Resectable Early-Stage Gastric and GEJ Cancers
Mohit Manrao, SVP, Head of US Oncology at AstraZeneca, shared a post on LinkedIn:
“This post is intended for a US audience:
AstraZeneca announced today that the FDA has granted Priority Review for its supplemental Biologics License Application (sBLA) for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. Patients in the MATTERHORN Phase III trial who received the regimen saw improvement in event-free survival: a 29% reduction in risk of disease progression, recurrence, or death compared to chemo alone.
Approximately one in four gastric cancer patients experience a recurrence within one year, even with curative intent surgery. But the MATTERHORN study is showing potential to transform event-free survival outcomes.
We’re hopeful that moving treatment earlier and attacking gastric/GEJ cancers from multiple angles will lead to better outcomes for patients. We’re encouraged by the FDA’s Priority Review and look forward to the next steps.
Read more about today’s announcement.”
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