Shots:

• The US FDA has issued a CRL to the BLA of retifanlimab. The BLA submission is based on P-II POD1UM-202 trial assessing retifanlimab in prior treated patients with LA or m-SCAC who have progressed on or were ineligible for or intolerant of Pt. based CT
• The FDA stated that an additional data is needed to demonstrate the clinical benefit of retifanlimab for advanced or metastatic SCAC
• Incyte is reviewing the letter and will discuss the next steps with the FDA. Retifanlimab is a PD-1 inhibitor and is currently under evaluation as a monothx. for patients with MSI-h endometrial cancer- MCC & SCAC and in combination with Pt.-based chemotherapy for patients with NSCLC and SCAC

­ Ref: Businesswire | Image: StraitTimes