The three novel chemotherapy agents (Revlimid, Velcade, Thalomid) now commonly used to treat multiple myeloma have been so successful it has created an unforeseen problem. According to Dr. Shaji Kumar with Mayo Clinic, improved outcomes for the majority of myeloma patients using these drugs makes it more difficult to bring other, new drugs to market. For those of you not familiar with the FDA drug approval process, one of the major criteria for fast-tracked approval of new cancer agents is the drug’s ability to significantly improve the outcome for patients as compared to the current standard of care. So, if Velcade allows patients to control their myeloma for, say an average of two years, any new drug needs to exceed that benchmark. This is a problem. Since myeloma tends to respond to a number of different therapies, the more new, different drugs that can be developed the better, even if they only work for a limited amount of time. In addition, clinical studies are now required to use larger groups of patients, who must be followed for longer periods of time. This may delay the approval of many new drugs which would otherwise be ready for market. Unexpected road-blocks that may adversely affect myeloma patients today and in the future. More about what can be done to speed-up the process tomorrow.
Feel good and keep smiling! Pat