At the CRC (CLL Research Consortium) meeting in April 2015, I had the opportunity to interview several of the chronic lymphocytic leukemia researchers including Dr. John Byrd out of Ohio State University.
Dr. Byrd discusses the FDA approval process to help get needed drugs to market.
Take Away Points:
- FDA approval can take up to 10 years using the traditional pathways.
- 4 new drugs have recently received FDA approval for CLL:
- Ofatumumab (trade name Arzerra) – a monoclonal antibody
- Obinutuzumab (trade name Gazyva) – a monoclonal antibody
- Ibrutinib (trade name Imbruvica) –an oral kinase inhibitor
- Idelalisib (trade name Zydelig) –an oral kinase inhibitor
- Breakthrough status can cut approval time in half.
- It is important to be well-informed of the details of the clinical trials and of the trial medication.
- Look for a fair cross-over design allowing access to other trial arms if your CLL progresses during treatment.
In my interview with Dr. Byrd, he discusses the continuing good news with CLL therapies and the emerging trials using combination of drugs to get to MRD (minimal residual disease) negative status, which may be a powerful surrogate marker for a very durable remission and even overall survival.
This allows possible shorter trials and quicker approval.
For more on crossover and equipoise in trial design please watch this powerful patient story and read the important linked opinion piece by Dr. Susan O’Brien.
For more on clinical trials in general including explanations of the various “phases” of trials, please see this section and the associated link.
Here is the interview with Dr. Byrd.
Brian Koffman 9/28/15