Cell and gene therapies are treatments designed to address disease in a different way. Gene therapies add, replace or change genetic material inside the body. Cell therapies use living cells as the treatment. Some are made from a patient's own cells, while others use donor cells. Because these treatments can be complex to deliver and may carry significant costs, plan sponsors need a clear view of what has been approved, what may be coming next and what those changes could mean for benefits and member support.
The Q3 Evernorth Cell and Gene Therapy Pipeline Report brings those developments together in one place. It is designed to help plan sponsors monitor quarterly changes in the market and use that information to support longer-term planning. This past quarter’s overview focuses on three practical questions: What changed recently? What is approaching an FDA decision? What should plan sponsors be watching now?
Two recent approvals show how the market is changing
Two 2026 approvals illustrate the range of conditions now being addressed. In August, the FDA granted accelerated approval to Tudriqev, used with nivolumab for certain adults with advanced melanoma whose disease progressed after previous treatment. In September, the FDA approved Fayuvi, the first gene therapy for children with Sanfilippo syndrome type A, a rare inherited condition that progressively affects the brain and nervous system.
These approvals are different in disease area and patient population, but together they show why the pipeline matters. Cell and gene therapies are not developing along a single path. They are advancing across cancer, rare disease and other categories, each with different coverage, provider and member-support needs.
One near-term therapy to watch
Doruxapapogene ralaplasmid, also known as INO-3107, is under FDA review for recurrent respiratory papillomatosis. This rare condition causes growths in the airway that can return after removal and may require repeated procedures. The September 2026 pipeline report lists an FDA action date of October 30, 2026. If approved, the therapy would give plan sponsors another example of a treatment that may change not only drug coverage, but also how care is coordinated around procedures, specialists and follow-up.
Why this matters beyond one approval
The bigger story is the breadth of the pipeline. The report tracks therapies across oncology, rare and inherited diseases, ophthalmology, neurology, cardiovascular disease and metabolic disorders. Some programs target very small populations. Others are being studied for conditions that affect more people. Timing can also shift as products move through clinical development and FDA review.
For plan sponsors, the goal is not to predict every approval. It is to build a repeatable way to monitor change and prepare for different scenarios. That means looking beyond the approval date and considering the full member journey, including how an eligible member is identified, where treatment is delivered, which specialists and facilities are needed, and what follow-up support may be required.
A practical planning checklist for plan sponsors
Monitor newly approved therapies and products approaching FDA decisions.
Review whether current medical, pharmacy and specialty-care processes are ready to support access.
Consider how site of care, provider availability and follow-up requirements may affect the member experience.
Plan for financial uncertainty, since timing, eligible populations and real-world use can change.
Use quarterly and monthly pipeline updates to keep benefit, clinical and financial teams aligned.
Preparing for what comes next
The Q3 pipeline update shows continued movement across multiple disease areas. Recent approvals provide concrete examples of how quickly the landscape can change, while therapies nearing an FDA decision offer a view into what may come next. For plan sponsors, staying informed can support earlier conversations about access, affordability, care delivery and member support.
To stay informed between quarterly outlooks, subscribe to the Evernorth Gene Therapy Pipeline Report.
To better understand how the cell and gene therapy pipeline could affect your organization, engage your account team directly.
