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FDA Approves Libtayo as First Adjuvant Therapy for High-Risk CSCC

The decision follows phase 3 data showing a 68% reduction in the risk of recurrence or death.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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Overview

  • The authorization covers adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.
  • In the 415-patient phase 3 C-POST study, Libtayo reduced the risk of recurrence or death vs placebo by 68% (hazard ratio 0.32; P < .0001), with median disease-free survival not reached vs 49.4 months.
  • The approval introduces the first immunotherapy option in the adjuvant CSCC setting, moving treatment earlier than previously limited use in advanced disease.
  • The label allows 350 mg every 3 weeks for 12 weeks followed by 700 mg every 6 weeks, or 350 mg every 3 weeks until recurrence, unacceptable toxicity, or up to 48 weeks.
  • Safety information warns of immune-mediated adverse events, infusion reactions, complications with allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.