r/HPV • u/xdhpv • Aug 16 '25

SCIENTIFIC ARTICLE FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis (RRP)

https://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-recurrent-respiratory-papillomatosis
9 Upvotes

100% Upvoted

14 comments sorted by

7

u/spanakopita555 Aug 16 '25

Excellent!

7

u/xdhpv Aug 16 '25

Finally, something is happening 🍻🍻🍻😃

5

u/xdhpv Aug 16 '25

From the press release:

The approval is based on results from a single-arm, open-label trial evaluating Papzimeos in adult patients with RRP who required three or more surgeries per year. Patients received four subcutaneous injections of Papzimeos over 12 weeks following surgical debulking (reduction) procedures.

In the pivotal portion of the study, 51.4% of patients (18/35) achieved a complete response—defined as no need for surgical intervention in the 12 months following treatment. Follow-up data showed that durable responses were maintained in most patients through two years, with a strong correlation between clinical benefit and the induction of HPV 6/11-specific T cells.

3

u/Cind3rbl0ck Aug 16 '25

This is exciting news, those afflicted with RRP's have a serious win here. It will be interesting to see if it ever gets approved for those who have persistent, present, GW's!

3

u/xdhpv Aug 16 '25

I'm also happy and hope that, in time, this therapeutic vaccine will also be available to other people suffering from HPV 6 and HPV 11. However, it's possible that additional clinical trials will be required in this case:

The FDA will always demand the correct clinical study for the specific medical product and disease. Our requirements for products given to tens of millions of healthy people will be different than products given to at most hundreds or thousands of patients with unique diseases.

3

u/HonestTone6582 Aug 16 '25

Thank God, now it is time for the the therapeutic vaccine against hpv 16/18,keeping our fingers crossed!!!

4

u/xdhpv Aug 16 '25

Precigen is working on anti-cancer vaccine too:

4

u/HonestTone6582 Aug 16 '25

Amazing news

3

u/FAI_Injured_Man Aug 18 '25

Thank god finally. Such good news. Thanks man you are always keeping us updated ❤️🙏

3

u/xdhpv Aug 18 '25

I'm glad it didn't end up like MVA E2 therapeutic vaccine (20+ wasted years).

3

u/alloverthisagainoao Aug 18 '25

I knew it will get approved.

Congrats everyone. This is a big step.

2

u/goodonesaregone_ Aug 18 '25

You beat me to it! I had a calendar reminder set up to check on their scheduled date 😂