Gene therapy developed in Kuopio approved by the FDA

Ferring Pharmaceuticals received approval from the US Food & Drug Administration (FDA) for Adstiladrin, a new, first-of-its-kind bladder cancer gene therapy.

Adstiladrin has been approved for the treatment of adult patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer. The development of the novel gene therapy product started in the 1990s in Kuopio, and the approval comes after decades of research.

The product will be manufactured by FinVector in Kuopio, and it is a major milestone for the company as well as the Finnish gene therapy research community.

Further reading:

FinVector press release

Ferring press release

FDA approval

Boorjian SA, Alemozaffar M, Konety BR, Shore ND, Gomella LG, Kamat AM, Bivalacqua TJ, Montgomery JS, Lerner SP, Busby JE, Poch M, Crispen PL, Steinberg GD, Schuckman AK, Downs TM, Svatek RS, Mashni J Jr, Lane BR, Guzzo TJ, Bratslavsky G, Karsh LI, Woods ME, Brown G, Canter D, Luchey A, Lotan Y, Krupski T, Inman BA, Williams MB, Cookson MS, Keegan KA, Andriole GL Jr, Sankin AI, Boyd A, O’Donnell MA, Sawutz D, Philipson R, Coll R, Narayan VM, Treasure FP, Ylä-Herttuala S, Parker NR, Dinney CPN. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Lancet Oncol. 2021 Jan;22(1):107-117. https://doi.org/10.1016/S1470-2045(20)30540-4

Mitra AP, Narayan VM, Mokkapati S, Miest T, Boorjian SA, Alemozaffar M, Konety BR, Shore ND, Gomella LG, Kamat AM, Bivalacqua TJ, Montgomery JS, Lerner SP, Busby JE, Poch M, Crispen PL, Steinberg GD, Schuckman AK, Downs TM, Svatek RS, Mashni J, Lane BR, Guzzo TJ, Bratslavsky G, Karsh LI, Woods ME, Brown GA, Canter D, Luchey A, Lotan Y, Krupski T, Inman BA, Williams MB, Cookson MS, Keegan KA, Andriole GL, Sankin AI, Boyd A, O’Donnell MA, Philipson R, Ylä-Herttuala S, Sawutz D, Parker NR, McConkey DJ, Dinney CPN. Antiadenovirus Antibodies Predict Response Durability to Nadofaragene Firadenovec Therapy in BCG-unresponsive Non-muscle-invasive Bladder Cancer: Secondary Analysis of a Phase 3 Clinical Trial. Eur Urol. 2022 Mar;81(3):223-228. https://doi.org/10.1016/j.eururo.2021.12.009