My very dear friend and advocate supreme, Jan Manarite, from PCRI has sent me an update on MDV3100 (enzalutamide). As usual her information is important, so I thought I would pass it on today.
• She points out that once the FDA approves MDV3100 (I am going to work on the assumption that it will be approved), it will still take some weeks before we see it in our pharmacy. When Zytiga was first approved it took almost a month before it became available in the pharmacy. So, my hope is that we will see it in the pharmacy by the end of this year.
• Enzalutamide will probably be expensive. It will probably be priced similarly to Zytiga, which is about $5,000 a month. We have every reason to believe that prescription insurance should cover this expense, minus any co-pays.
• Jan feels and I concur that the FDA label will likely look very much like the label for Zytiga. The label will probably read for the treatment of castrate resistant prostate cancer (CRPC) that is metastatic once Taxotere has failed.
• Enzalutamide should get a new brand name when approved. Enzalutamide will become its generic name.
The following is a press release from Medivation and Astellas Pharm Inc.:
Medivation and Astellas Announce PDUFA Action Date for Enzalutamide NDA
SAN FRANCISCO, CA and TOKYO — (Marketwire) — 08/03/12 — Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012 for the review of the investigational agent enzalutamide (formerly MDV3100) New Drug Application (NDA) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy. The companies announced on July 24, 2012 that the FDA accepted the enzalutamide NDA filing for review and granted Priority Review Designation.
Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. Enzalutamide inhibits androgen receptor signaling in three distinct ways: it inhibits 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors.
In the Phase 3 AFFIRM trial common side effects observed more frequently in enzalutamide as compared with placebo-treated patients included fatigue, diarrhea and hot flush. Seizure was reported in less than 1% of enzalutamide-treated patients. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the enzalutamide group than in the placebo group.
Joel T Nowak, M.A., M.S.W.