(News Bulletin 247) – Merck today announced that the U.S. Food and Drug Administration (FDA) has agreed to review a new Supplemental Biologics License Application (sBLA) for the combination of Keytruda with a chemotherapy containing fluoropyrimidine and platinum, as part of the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The sBLA is based on data from a trial in which Keytruda plus chemotherapy demonstrated a ‘statistically significant’ improvement in overall survival (OS) compared to chemotherapy alone.
‘We are committed to working closely with the FDA to bring Keytruda to more patients with gastric and gastroesophageal junction cancer who need additional treatment options that may help them live longer’ , commented Dr. Scot Ebbinghaus, vice president of global clinical development at Merck Research Laboratories.
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