PDS Biotechnology has scheduled a Type C Meeting with the FDA to discuss the proposed amendment to the Phase 3 VERSATILE-003 trial for PDS0101 in HPV16-positive cancers.
The meeting aims to enable an accelerated approval pathway based on positive results from the VERSATILE-002 trial.
The proposed amendment would change the PFS endpoint to a surrogate primary endpoint, potentially expediting regulatory submission.
Type C Meeting Scheduled
The Type C Meeting with the FDA has been accepted and scheduled to discuss an accelerated approval pathway for PDS0101.
Positive VERSATILE-002 Results
The VERSATILE-002 trial showed promising PFS and mOS results in patients with CPS ≥ 1, leading to the proposed amendment in the VERSATILE-003 trial.
Path to Regulatory Submission
The Company aims to expedite the regulatory submission process while maintaining mOS and safety assessment as primary endpoints for full FDA approval.
- If the proposed amendment is approved, the Company may have a faster route to bring PDS0101 to patients in need.
- Shortening the time to primary endpoints could accelerate the availability of the treatment, potentially benefiting cancer patients.
PDS Biotechnology's move towards an accelerated approval pathway reflects its commitment to delivering innovative treatments to cancer patients efficiently. The positive data from VERSATILE-002 has paved the way for a streamlined regulatory approach.