The US FDA Declines to Approve Incyte’s Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal

July 26, 2021 Auto Bot FDA, Incyte, regulatory 0

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

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: StraitTimes

The post The US FDA Declines to Approve Incyte’s Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal first appeared on PharmaShots.