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# Fast Track Granted for Pancreatic Cancer Drug
- URL: https://www.fdaweb.com/fast-track-granted-for-pancreatic-cancer-drug/
- Published: 2024-05-23T12:00:00.000Z
- Updated: 2026-09-14T14:31:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157052

FDA has granted Theriva Biologics a fast-track designation for its lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma.

VCN-01 is described by the company as a systemically administered oncolytic adenovirus designed to “selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode of action enables VCN-01 to exert multiple antitumor effects by **(i)** selectively infecting and lysing tumor cells; **(ii)** enhancing the access and perfusion of co-administered chemotherapy products; and **(iii)** increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products.”

Theriva says the therapy has been administered to over 80 patients in Phase 1 and investigator-sponsored clinical trials of different cancers, including pancreatic ductal adenocarcinoma (PDAC) in combination with chemotherapy, head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection).

Currently, VCN-01 is being evaluated in VIRAGE, a multinational Phase 2b clinical study, in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy for patients with PDAC. Previously, the agency granted an orphan drug designation to VCN-01 for treating PDAC.