Efficacy

ADSTILADRIN Delivers on its Innovation With Proven and Durable CRs

Study design

The safety and efficacy of ADSTILADRIN (nadofaragene firadenovec-vncg) were evaluated in CS-003, an open-label, multicenter, single-arm study of 103 patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer (NMIBC),
98 of whom had BCG-unresponsive carcinoma in situ (CIS) with or without papillary tumors and could be evaluated for response. The primary endpoint was complete response (CR) in CIS ± high-grade Ta/T1 at any time after the first
instillation.¹

ADSTILADRIN has proven and durable CRs
out to 5 years

51^%

achieved CR by month 3 (after 1 instillation) (95% CI, 41%-61%).¹*^†

1 YEAR

46^%

2 YEARs

36^%

3 YEARs

25^%

of patients who had a CR at month 3 remained
high-grade recurrence free.^1-3*^†

At 5 years, 11% of patients with a CR at month 3 remained high-grade recurrence free.³*

Study limitation: Patients were not reinduced if a CR did not occur after the first dose. Patients may have also been lost to follow-up or switched therapy after 1 year and were considered a treatment failure due to the protocol in CS-003.^1,3

DURATION OF
RESPONSE (DOR)*

3-57
 MONTHS​3,4

Meaning, some patients
 remained NMIBC free for​
                                    57 
MONTHS3,4​
Median DOR was 9.7 MONTHS1​*

ADSTILADRIN provides the longest-term follow-up efficacy data
for an intravesical high-risk NMIBC treatment³

Low incidence of cystectomy at

5 years

Of the patients who achieved a CR,
13 out of 55 underwent a

cystectomy within the 5-year
follow-up⁵
Median follow-up time was 48.9 months^5‡

Low progression to muscle-invasive
bladder cancer at 5 years

Of the patients who received at
least 1 dose of ADSTILADRIN,
4
out
of 103 patients experienced clinical progression^§ to
MIBC^3,4

Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal⁴
This exploratory analysis is not in the Prescribing Information. It is being provided for descriptive purposes; results require cautious interpretation, as radical cystectomy may have occurred after patient discontinuation

When BCG Fails, Make ADSTILADRIN

Your First Choice for Bladder Preservation

*Based on patients (n=50) who achieved a CR; reflects period from the time CR was achieved.¹

^†N equals 25 at 1 year, 20 at 2 years, 14 at 3 years, and 6 at 5 years.³

^‡Following the initial 12-month treatment period, patients entered a 4-year follow-up monitoring period,
irrespective of whether ADSTILADRIN treatment was continued. Patients who had
high-grade recurrence were withdrawn from treatment and had follow-up data for cystectomy status collected annually for up to 5 years.³

^§Clinical progression to MIBC was assessed by biopsy, and does not include the assessment from those patients

after undergoing radical cystectomy.⁶

BCG, Bacillus Calmette-Guérin; CIS, carcinoma in situ; CR, complete response; MIBC, muscle-invasive bladder cancer; T1, tumor invades lamina propria; Ta, noninvasive papillary carcinoma.

Watch video

Hear From a Board-Certified Urologist

“In bladder oncology, I think that this represents a transformative breakthrough.”
Lawrence Karsh, MD, FACS, treated patients in the ADSTILADRIN clinical trial

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References: 1. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; October 2025. 2. Boorjian SA, Alemozaffar M, Konety BR, et al. 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;22(1):107-117. doi:10.1016/S1470-2045(20)30540-4 3. Narayan VM, Boorjian SA, Alemozaffar M, et al. Efficacy of intravesical nadofaragene firadenovec for patients with Bacillus Calmette-Guérin-unresponsive nonmuscle-invasive bladder cancer: 5-year follow-up from a phase 3 trial. J Urol. 2024;212(1):1-12. doi:10.1097/JU.0000000000004020 4. Data on file. Ferring Pharmaceuticals, Inc. July 2024. 5. Narayan VM, et al. 2024 SUO Annual Meeting. 6. Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Supplement. Lancet Oncol. 2021;22(1):107-117. doi:10.1016/S1470-2045(20)30540-4

Important Safety Information

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) with carcinoma in situ (CIS) with or without papillary tumors.

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:

Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.

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 glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-10881-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING1-888-FERRING.

Please see full Prescribing Information for ADSTILADRIN.

Efficacy

ADSTILADRIN Delivers on its Innovation With Proven and Durable CRs

Study design

ADSTILADRIN has proven and durable CRs
out to 5 years

3 months (primary endpoint)

achieved CR by month 3 (after 1 instillation) (95% CI, 41%-61%).¹*^†

46^%

36^%

25^%

DURATION OF
RESPONSE (DOR)*

Meaning, some patients
remained NMIBC free for

Low incidence of cystectomy at

5 years

Low progression to muscle-invasive
bladder cancer at 5 years

Hear From a Board-Certified Urologist

Sign Up to Receive Information and Updates on ADSTILADRIN (nadofaragene firadenovec-vncg)

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Important Safety Information

INDICATION

IMPORTANT SAFETY INFORMATION

NEW CLINICAL
DATA

Efficacy

ADSTILADRIN Delivers on its Innovation With Proven and Durable CRs

Study design

ADSTILADRIN has proven and durable CRs out to 5 years

3 months (primary endpoint)

achieved CR by month 3 (after 1 instillation)​ (95% CI, 41%-61%).1*†​

46%

36%

25%

DURATION OF RESPONSE (DOR)*

Meaning, some patients remained NMIBC free for​

Low incidence of cystectomy at 5 years

Low progression to muscle-invasive bladder cancer at 5 years

Hear From a Board-Certified Urologist

Sign Up to Receive Information and Updates on ADSTILADRIN (nadofaragene firadenovec-vncg)

Your Information

Your Mailing Address

Important Safety Information

INDICATION

IMPORTANT SAFETY INFORMATION

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NEW CLINICAL DATA

ADSTILADRIN has proven and durable CRs
out to 5 years

achieved CR by month 3 (after 1 instillation) (95% CI, 41%-61%).¹*^†

46^%

36^%

25^%

DURATION OF
RESPONSE (DOR)*

Meaning, some patients
remained NMIBC free for

Low incidence of cystectomy at

5 years

Low progression to muscle-invasive
bladder cancer at 5 years

NEW CLINICAL
DATA