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ArticleFDA Updates

FDA approves Papzimeos (zopapogene imadenovec-drba) for recurrent respiratory papillomatosis

Papzimeos is the first and only FDA-approved therapy for the treatment of adults with RRP.

Introduction: PAPZIMEOS™ is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis.

Dosage: 5×10¹¹ particle units (PU) per injection, given SC 4 times over 12 weeks.

Usage: Prior to first dose, surgical debulking of visible papillomas is recommended to minimize residual disease. Supplied as a single-dose vial containing 5×10¹¹ PU in 1 mL suspension.

Contraindications: None.

Warnings & Precautions: Injection-site reactions Monitor patients for at least 30 minutes after Rx. Thrombotic events.

Adverse reactions: Most common (≥5%): injection-site reactions, fatigue, chills, fever, muscle pain, and nausea.

Reference: FDA
Clinical Inshorts by ClinicHours

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