Nadofaragene firadenovec

Overview

Nadofaragene firadenovec (nadofaragene firadenovec-vncg) is a recombinant non-replicating adenovirus serotype 5 vector containing a transgene encoding human interferon alfa-2b (IFNα2b). It was approved by the FDA on December 2022 for the treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. It is the first gene therapy approved by the FDA for the treatment of bladder cancer. BCG-unresponsive NMIBC has a high recurrence and is notably difficult to treat. Most patients with this condition undergo radical cystectomy since other non-surgical treatments are far less effective. The use of nadofaragene firadenovec provides a therapeutic alternative to patients seeking non-surgical alternatives for the treatment of BCG-unresponsive NMIBC. Nadofaragene firadenovec is formulated with an excipient (Syn-3) that facilitates gene transfer across the urothelium and promotes the transduction of IFNα2b. The localized expression of this gene induces anti-tumor effects. Nadofaragene firadenovec also has a manageable adverse event profile. Compared to pembrolizumab, a smaller proportion of patients experienced grade 3-4 adverse events (4% vs 12.7%).

Indication

Nadofaragene firadenovec is indicated for the treatment of adult patients with high-risk Bacillus CalmetteGuérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Associated Conditions

High risk BCG-unresponsive non-muscle invasive bladder cancer

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)	2025/04/16	NCT06929286	Phase 3	Recruiting	Memorial Sloan Kettering Cancer Center
Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis	2024/10/31	NCT06668493	Phase 1	Recruiting	Ferring Pharmaceuticals
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer	2024/08/09	NCT06545955	Phase 3	Recruiting	Ferring Pharmaceuticals
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer	2024/07/19	NCT06510374	Phase 3	Recruiting	Ferring Pharmaceuticals
A Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.	2024/04/30	NCT06390111	Phase 4	Withdrawn	Ferring Pharmaceuticals
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States	2023/09/07	NCT06026332	N/A	Recruiting	Ferring Pharmaceuticals
Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma	2018/10/18	NCT03710876	Phase 3	Active, not recruiting	Ferring Ventures Limited
Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer	2012/09/18	NCT01687244	Phase 2	Completed	FKD Therapies Oy
1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer	2010/07/15	NCT01162785	Phase 1	Completed	M.D. Anderson Cancer Center
Combination Gene Transfer and Chemotherapy	2010/05/07	NCT01119664	Phase 1	Completed	Abramson Cancer Center at Penn Medicine

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ADSTILADRIN	Ferring Pharmaceuticals	55566-1050	INTRAVESICAL	300000000000 {VP} in 1 mL	9/30/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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