“The FDA has set up PDUFA date of September 23 and the European Medicines Agency is reviewing the application.”

In context

“six-week dosing regimen of the investigational subcutaneous fixed-dose combination of pembrolizumab and ver hyaluronidase alpha. With chemotherapy versus intravenous Keytruda with chemotherapy. The study met its dual primary endpoints demonstrating non-inferior pharmacokinetics for subcutaneous pembrolizumab versus intravenous Keytruda. Consistent results were also reported for efficacy and safety endpoints across treatment arms. The median time for administration of subcutaneous pembrolizumab given every six weeks was approximately two minutes. A meaningful reduction compared to the time needed to administer Keytruda as an IV infusion. Of note, at the American Association Cancer Research meeting next week, data from another study evaluating a three-week dosing regimen will be presented. The FDA has set up PDUFA date of September 23 and the European Medicines Agency is reviewing the application. We are seeking approval for both a six-week and a three-week dosing option. If approved, subcutaneous pembrolizumab would provide an important option for health care systems and patients, most notably for those in earlier stage settings Keytruda continues to have an unparalleled breadth of approvals and a significant impact for patients. The FDA granted priority review for Keytruda as part of a perioperative treatment regimen for patients newly diagnosed with stage III or IVA resectable locally advanced head and neck squamous cell carcinoma based on the keynote six eighty-nine study. The PDUFA date is June 23. As a reminder, this is the first trial in twenty years for patients with resected locally advanced head and neck squamous cell carcinoma and the first phase three trial to show a st”