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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

214
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
214
Bioequivalence studies: Biowaivers01:13

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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
197

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Expansion of Human Peripheral Blood γδ T Cells using Zoledronate
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Zopapogene Imadenovec: First Approval.

Arnold Lee1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. mdt@adis.com.

Molecular Diagnosis & Therapy
|November 8, 2025
PubMed
Summary

Zopapogene imadenovec, an immunotherapy for recurrent respiratory papillomatosis, achieved complete responses in about half of adult patients. This treatment harnesses an adenoviral vector to target HPV types 6 and 11, fostering a T-cell-friendly environment.

Area of Science:

  • Oncology
  • Immunotherapy
  • Virology

Background:

  • Recurrent respiratory papillomatosis (RRP) is a rare disease caused by specific human papillomavirus (HPV) types.
  • Current treatments for RRP can be invasive and may not prevent disease recurrence.

Purpose of the Study:

  • To summarize the development and milestones of zopapogene imadenovec.
  • To highlight the first approval of zopapogene imadenovec for adult RRP patients.

Main Methods:

  • Zopapogene imadenovec is a non-replicating adenoviral vector-based immunotherapy.
  • It is designed to stimulate an immune response against HPV types 6 and 11.

Main Results:

  • Zopapogene imadenovec demonstrated efficacy in treating adult patients with RRP.

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  • Approximately 50% of treated patients achieved complete responses.
  • A favorable papillary microenvironment for T cells was observed in complete responders.

    • Conclusions:

    • Zopapogene imadenovec represents a novel therapeutic option for RRP.
    • The immunotherapy's success marks a significant advancement in managing this condition.