Rapid advances in the development of treatments for advanced prostate cancer are creating some unique opportunities for access to these treatments at no cost to patients under “Early/Expanded Access Programs.”
These opportunities become available when phase 3 clinical trial results are proven effective and the trials are halted. However, there is still a Food and Drug Administration (FDA) process that companies must complete before these proven treatments can be “marketed” to the public. This process takes many months before it is completed.
I serve as a member of a committee called “The Early/Expanded Access Program for Prostate Cancer Patients.” This committee advocates for early access to those treatments that have completed the phase 3 clinical trial and awaits final FDA approval. This is information about the committee and its purpose.
We are pleased and excited that Astellas/Medivation has made MDV3100 (Enzalutamide), and Bayer has made Radium-223 Chloride (Alpharadin) available under the early access program. Both these treatments are for “advanced prostate cancer patients.” Information about each is included in the June Treatments and Clinical Trials e-newsletter.
These early access program opportunities are especially appealing to those patients that have urgent needs, and also for patients who may have difficulties in affording these treatments once they receive final FDA approval. I urge advanced prostate cancer patients to review the information on each of the treatments to determine if there could be a personal benefit.