The US Food and Drug Administration (FDA) has approved Ferring Pharmaceuticals’ adenovirus vector-based gene therapy, Adstiladrin (nadofaragene firadenovec-vncg).

Adstiladrin is an intravesical therapy administered to the patient at three-month intervals. The therapy is used to treat adults with high-risk Bascillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) that works by targeting the individuals’ bladder wall cells to boost the body’s natural defenses to fight cancer.

According to the firm, the FDA approval is based on positive Phase III clinical trial results. The results demonstrated that over half of the patients (51%) of the cohort achieved a complete response (CR) at the three-month mark and out of the 51%, 46% of the patients continued to remain free of high-grade recurrence at one year.

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“This approval provides healthcare professionals with an innovative treatment option for patients with high-risk non-muscle invasive bladder cancer that is unresponsive to BCG therapy,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“Today’s action addresses an area of critical need. The FDA remains committed to facilitating the development and approval of safe and effective cancer treatments.”

The Swiss company says that bladder cancer is one of the more common forms of cancer and a majority of newly diagnosed cases – around 75%-80% – are classified as NMIBC with high rates of recurrence and risk of the cancer spreading.

“Ferring has been working diligently to realize the potential of gene therapy for bladder cancer patients, where there has long been a critical unmet need for additional treatment options,” said Armin Metzger, executive vice president and chief science officer, Ferring Pharmaceuticals. “

“We are proud to have achieved this critical milestone towards fulfilling the potential of Adstiladrin, a first-of-its-kind therapy, for bladder cancer patients. Adstiladrin is the culmination of a complex research, development, and production process, and we are grateful to the teams, physicians and patients who have helped us reach this approval.”

The firm anticipates that Adstiladrin will be commercially available in the US during the second half of 2023, following a production capacity expansion which will see the Ferring add commercial scale vector manufacturing for oncology.