“The PDUFA date is June 23.”

In context

“eting 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 statistically significant event-free survival benefit of neoadjuvant plus adjuvant therapy for newly diagnosed patients in this setting. Earlier intervention has the potential to improve outcomes, and reduce the burden of disease in this patient population. Results will be submitted to regulatory agencies and, if approved, this will mark the tenth indication of a KEYTRUDA-based regimen for the treatment of an earlier stage cancer. Detailed findings will be presented at the American Association for Cancer Research meeting next week where it may be important to scrutinize the Kaplan Meier plot the divergence of the”