Ferring Pharmaceuticals on Track to Deliver ADSTILADRIN® (nadofaragene firadenovec-vncg) to Patients in Early Experience Program in September 2023
Parsippany, NJ – June 26, 2023 – Ferring Pharmaceuticals today announced it will make the intravesical gene-therapy ADSTILADRIN® (nadofaragene firadenovec-vncg) available for physicians to prescribe to their patients through an Early Experience Program beginning September 2023 in recognition of the patients who may be out of other treatment options.
The ADSTILADRIN Early Experience Program will be offered initially to a mix of clinical trial sites that participated in the Phase 3 study and community clinical sites with the highest eligible adult patients with non-muscle invasive bladder cancer (NMIBC) ensuring a diverse representation of patients will have access to the product. Ferring representatives will begin reaching out to clinics throughout Summer 2023 to gain agreement to participate in the ADSTILADRIN Early Experience Program.
“Our commitment to every patient who starts on ADSTILADRIN is the ability to continue for the duration of their treatment and that health care providers treating patients will have a positive experience,” said Shetal Vyas, Vice President and General Manager, U.S. Uro-Oncology, Ferring. “At Ferring, patients are at the forefront of our decision making, and as we work to ensure future full market availability in the U.S. as early as possible, we recognize there are patients who may be out of other options and need ADSTILADRIN now.”
ADSTILADRIN was approved by the U.S. Food & Drug Administration (FDA) in December 2022 for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors. It is the first and only FDA-approved intravesical gene therapy for adults with NMIBC who no longer respond to standard therapy.
Ferring worked closely with the bladder cancer community—including doctors, patient advocates, and payers—to inform the Early Experience Program with the aim of providing available product to as many patients as possible. This temporary program is intended to address unmet patient needs as the Company scales up manufacturing quickly and responsibly, with two new, state-of-the-art facilities under construction in Finland and the U.S. These two new facilities will be dedicated to manufacturing ADSTILADRIN for future long-term supply so that every clinic and patient who needs it will have access. As supply increases over time, more clinics will be able to join the ADSTILADRIN Early Experience Program.
To sign up for updates, please visit www.ADSTILADRINHCP.com.
ABOUT ADSTILADRIN
ADSTILADRIN® (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical gene therapy for 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. It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered 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 quantities of interferon alfa-2b protein, a naturally-occurring protein the body uses to inhibit tumor growth. 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-grade, 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).
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 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, uro-oncology and in specialty areas within gastroenterology, including microbiome therapeutics, and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.ferringusa.com.
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For more information, please contact:
Carol Ready
Director, Brand Communications
+1-973-765-7307
carol.ready@ferring.com