FDA gives Ferring go-ahead for Adstiladrin gene therapy manufacturing
Following a December approval, the FDA has now given Ferring Pharmaceuticals clearance to scale up its gene therapy manufacturing.
The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). This will allow the Swiss company to begin ramping up its drug substance manufacturing process with its sister company FinVector Oy in Kuopio, Finland ahead of its planned product launch.
The FDA approved Adstiladrin 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 in adult patients in December 2022. This is the first and only FDA-approved intravesical gene therapy for patients with this condition.Ferring Pharmaceuticals has a clinical development pipeline consisting of therapies for reproductive medicine and maternal health, urology and uro-oncology and more. The company currently has five approved therapies in the latter therapy areas, including Firmagon (degarelix), Minirin (desmopressin), and Testim (testosterone). Ferring plans to begin Adstiladrin production in the H2 2023, as part of an initial rollout in the US. The company aims to then increase supplies in 2024.
Finvector Oy is a Finnish biopharmaceutical company that specialises in current Good Manufacturing Practice (cGMP) manufacturing. In May 2022, Finvector began construction of a new viral vector manufacturing site, using the iCELLis manufacturing platform from Pall Corporation. This site will be used for Adstiladrin production. To support the increased capacity, the company expects to hire 500 more employees in the coming years.
Non-muscle invasive bladder cancer is characterised by cancer cells that remain only in the lining of the bladder. Common treatment options for the condition include bladder removal surgery, chemotherapy and/or administration of the BCG vaccine in the bladder. Bladder cancer is the sixth most common cancer in the US and the American Society of Clinical Oncology predicts that 82,290 adults will receive a diagnosis for bladder cancer in 2023.
Adstiladrin is a non-replicating vector-based gene therapy that activates interferon alpha 2b, causing the transcription and translation of genes that mediate antitumor effects. According to GlobalData, Adstiladrin is one of six therapies approved for the treatment of non-muscle invasive bladder cancer in the US, including two BCG vaccines. The therapy received approval based on positive Phase III trial (NCT02773849) results.
GlobalData is the parent company of Pharmaceutical Technology.
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