Scientists are always looking for new and better ways to treat mesothelioma. But one of the challenges they face in delivering their treatments to the public is getting those treatments approved. Approvals often come only after years of research, but some developers can Fast Track their treatments.
One of those developers is the Norwegian company Targovax. As they noted in a recent press release, they received FDA Fast Track approval for their ONCOS-102 treatment. This treatment uses viruses to activate the body’s immune response against the tumors the virus targets. With its Fast Track status, Targovax hopes to speed up its clinical development and the FDA review process.
What are the benefits of the Fast Track status?
It’s one thing to read that Targovax claims its Fast Track status should speed up its clinical development and regulatory reviews. It’s another thing to fully understand what that entails.
The development of any new treatment must progress through multiple stages. For most treatments, the FDA requires:
- A strong body of research suggesting that a new treatment approach may work
- Pre-clinical testing on animals and the collection of new data
- An application to begin clinical trials on humans
- Human trials that begin with sample sizes that start small and grow through subsequent phases
- Reviews of the clinical data and manufacturing facilities
- An application to distribute and market the treatment
- A review of any product labels
- Post-clinical reviews that draw upon data from treatments after FDA approval
Of course, all of this takes time. When it grants Fast Track status, the FDA is saying the treatment has great potential. The FDA generally reserves Fast Track status for treatments that break new ground on serious problems. And its approval of Fast Track status may indicate the FDA is willing to:
- Communicate more frequently with the developer
- Accept partial submissions of some early applications to keep the process moving forward
- Look favorably upon the developer’s request for a Prioritized Review
This means that even though the ONCOS-102 treatment is still in the early clinical stages, it may help mesothelioma victims before too long. That depends on how effective and safe it proves in trials. Currently, Targovax claims they’re testing the treatment on its own and paired with chemotherapy.
Why scientists continue to look for better treatments
Sadly, the truth is that doctors rarely diagnose mesothelioma until the disease has progressed to its later stages. By that time, many of the most effective treatment options, such as surgery, are no longer viable. If the FDA eventually approves the ONCOS-102 treatment, it will provide doctors another tool to use against the disease.
Since no two victim or cases are ever exactly the same, it’s important that doctors tailor their treatment plans to the individuals. Over the years, the development of newer and better treatments has helped doctors improve their patients’ survival rates. And because less invasive treatments tend to have fewer harmful side-effects, victims may also enjoy a better quality of life.