Ferring Announces Update to NCCN Guidelines Expanding Category 2A Recommendation for Nadofaragene Firadenovec-vncg (ADSTILADRIN ®) in Patients with BCG-Unresponsive NMIBC
PARSIPPANY, N.J.--( BUSINESS WIRE)--Ferring Pharmaceuticals announces that nadofaragene firadenovec-vncg (ADSTILADRIN ®) has been upgraded to a National Comprehensive Cancer Network ® (NCCN ®) Category 2A recommended option for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors (+Ta/T1) without carcinoma in situ (CIS) in the 2026 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®). 1
ADSTILADRIN is an FDA-approved non-replicating intravesical gene-therapy for the treatment of adult patients with high-risk BCG-unresponsive NMIBC CIS with or without papillary tumors (±Ta/T1), and is dosed once every three months. ADSTILADRIN is not approved by the FDA for BCG-unresponsive NMIBC with high-grade papillary Ta or T1 tumors without CIS, and the safety and effectiveness of ADSTILADRIN for BCG-unresponsive NMIBC with high-grade papillary Ta or T1 only tumors without CIS has not been established. For patients with high-risk NMIBC, intravesical BCG is recommended as the first-line standard-of-care, 2 yet many patients become unresponsive or experience recurrence, leaving limited effective treatment options. 1
Developed by panels of experts across multiple disciplines, the NCCN Guidelines are continually revised as new evidence emerges. They serve as a key reference for cancer treatment decision‑making and are broadly relied upon by providers, patients and payers. These guidelines describe some uses of medical products that are not approved by the FDA, and the safety and effectiveness of any unapproved use(s) have not been established.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall. 5 In the United States, bladder cancer is the sixth most common cancer, 3 fourth among men, 6 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025. 6 Historically, 75% of bladder cancer presents as NMIBC. 4 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease. 2
About ADSTILADRIN
ADSTILADRIN ® (nadofaragene firadenovec-vncg) is an FDA-approved intravesical non-replicating gene-therapy for the treatment of 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 (±Ta/T1). It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.
ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC, who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849 and final five-year follow-up analysis published in The Journal of Urology). 7-8
INDICATION
ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.
WARNINGS AND PRECAUTIONS:
DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use or oral administration.
USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.
ADVERSE REACTIONS: The most common (>10%) adverse reactions; including, laboratory abnormalities (>15%), were increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition (urination urgency), increased creatinine, hematuria (blood in urine), decreased phosphate, chills, pyrexia (fever) and dysuria (painful urination).
You are encouraged to report negative side effects of prescription drugs to FDA. Visit http://www.fda.gov/medwatch or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.
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About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a privately-owned, specialty, biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees.
For more information, please visit www.ferringusa.com, call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X.
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