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

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

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

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