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33m ago

FDA Approves Libtayo as First Immunotherapy for Adjuvant Treatment of High‑Risk CSCC

The decision rests on phase 3 data showing a 68% lower risk of recurrence or death versus placebo.

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
Libtayo was developed through the VelocImmune technology of Regeneron. Credit: lev radin/Shutterstock.com.
FDA Approves Adjuvant Cemiplimab for Cutaneous Squamous Cell Carcinoma | OncLive

Overview

  • Results from the 415‑patient phase 3 C‑POST trial showed median disease‑free survival not reached with cemiplimab versus 49.4 months with placebo (hazard ratio 0.32; P < .0001).
  • The indication covers adult patients with cutaneous squamous cell carcinoma at high risk of recurrence following surgery and radiation.
  • Prescribing guidance recommends 350 mg every 3 weeks for 12 weeks then 700 mg every 6 weeks, or 350 mg every 3 weeks until recurrence, unacceptable toxicity, or up to 48 weeks.
  • Safety information highlights immune‑mediated adverse effects, infusion‑related reactions, complications after allogeneic stem cell transplantation, and embryo‑fetal toxicity.
  • Regeneron’s approved filing excluded Catalent’s Bloomington, Indiana fill‑finish site following FDA observations that included improperly investigated contaminants, and the company says it is working with regulators to resolve issues.