Ferring Announces Full Availability of ADSTILADRIN® (nadofaragene firadenovec-vncg) in the U.S.

  • Patients with high-risk, non-muscle invasive bladder cancer now have greater access to the first and only FDA-approved intravesical gene therapy
  • With full supply of ADSTILADRIN ahead of schedule, Ferring ends the temporary ADSTILADRIN Early Experience Program
  • Enrollment in ABLE-41 U.S. Real-World Evidence Study is ongoing
Reno, Nevada (UroToday.com) -- Ferring Pharmaceuticals announced that ADSTILADRIN® (nadofaragene firadenovec-vncg) is now fully available across the U.S. for healthcare providers to prescribe for their adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Approved by the U.S. Food & Drug Administration (FDA) in December 2022, ADSTILADRIN is the first and only FDA-approved intravesical gene therapy for adults with NMIBC who no longer respond to standard therapy.

“From the day we received FDA approval, Ferring has been committed to making ADSTILADRIN available to every appropriate high-risk NMIBC patient quickly and responsibly, working collaboratively with the bladder cancer community to inform our approach,” said Bipin Dalmia, Senior Vice President, Global Head, Uro-Oncology Franchise at Ferring Pharmaceuticals. “With our significant manufacturing investments, we have achieved full product supply ahead of schedule. We are therefore ending our ADSTILADRIN Early Experience Program and look forward to bringing this novel therapy to every patient who needs it.”
In September 2023, Ferring initiated the ADSTILADRIN Early Experience Program to a mix of clinical trial sites that participated in the ADSTILADRIN Phase 3 study and community clinics with the highest number of appropriate patients with NMIBC. This temporary program represented Ferring’s commitment to treat as many patients as possible in the short term while ensuring every patient who started on ADSTILADRIN had the ability to continue therapy for the duration of their treatment. Now that full product supply is available ahead of schedule, Ferring can end the temporary ADSTILADRIN Early Experience Program and dramatically increase patient access.

“ADSTILADRIN represents an effective alternative therapy for patients with NMIBC who, historically, had very few options once they no longer responded to standard BCG therapy,” said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network, BCAN. “Increasing access to this innovative therapy offers the potential of what patients need most – safe, effective treatment options that bring hope.”

Ferring also initiated a non-interventional study, known as the “ADSTILADRIN in BLadder CancEr” (ABLE-41) U.S. Real World Evidence (RWE) Study (NCT06026332). This ongoing study is exploring early utilization, experiences, and outcomes of ADSTILADRIN in the routine care setting.

Source: Ferring Pharmaceuticals. (2024). Ferring Announces Full Availability of ADSTILADRIN® (nadofaragene firadenovec-vncg) in the U.S. [Press release]. https://ferringusa.com/?press=ferring-announces-full-availability-of-adstiladrin-nadofaragene-firadenovec-vncg-in-the-u-s.