Brittany Avin McKelvey, Vice President at LUNGevity Foundation, shared a post on LinkedIn:
“Patients with lung cancer in the US depend on a robust and efficient regulatory review process to receive the treatments of tomorrow. LUNGevity Foundation provided written comments to the proposed PDUFA VIII Enhancements:
We applaud FDA and industry for an agreement that integrates successful pilots into routine review practice, commits to greater transparency, and protects funding to restore review staff.
We recognize that each proposed enhancement will be dependent on implementation to deliver the greatest value and additional work is needed. As this heads to the Hill, we are focused on:
- Bringing more transparency to review outcomes, including by increased reporting for efficacy supplements
- Modernizing endpoints in a consistent, cross-Agency approach
- Speeding and aligning FDA engagement for precision oncology, particularly in companion diagnostic planning
- Protecting and rebuilding review expertise.
Andrea Ferris, President an CEO at LUNGevity Foundation, shared this post, adding:
“PDUFA VIII negotiations will help shape how FDA reviews new treatments, making this an important conversation for everyone affected by lung cancer. Our comments on PDUFA VIII reflect the rigor and care our team brings to this work.
I am proud that the quality of LUNGevity’s work and the trust we have built give us a meaningful voice at the table. We are proud to be one of only eight oncology organizations to participate in the PDUFA VIII consultations. Thank you Brittany Avin McKelvey!
This is an opportunity to help shape decisions that affect how quickly promising science becomes a treatment patients can receive.”
You can also read: ESMO 2026: 10 ADCs in Lung Cancer to Watch
