Posts tagged ‘abiraterone approval’
April 29th, 2011
Sally Church on Pharma Strategy Blog has written about the FDA approval yesterday of Ortho Biotech’s ($JNJ) abiraterone acetate, brand name Zytiga for the treatment of castration resistant prostate cancer in patients who have received prior chemotherapy with docetaxel.
The final data showed a 4.6 month increase in overall survival (OS) in these very sick patients in late stage disease. It is to be expected that the response will be significantly better in patients treated earlier.
As Sally states in her post, “it is good to see new treatment options emerge for the treatment of castrate resistant prostate cancer.”
Abiraterone treatment has been priced competitively by JNJ, with a treatment price of around $40K ($5,000 per month for a median treatment cycle of 8 months). As Sally notes “this is very fair.”
The commercial impact for sanofi-aventis is likely to be huge. It’s hard not to see elderly or frail patients preferring 4 pills a day compared to chemotherapy with a side-effect profile that is far from optimal. The price of abiraterone acetate (Zytiga) is lower than cabazitaxel (Jevtana), which was approved early last year. The market opportunity for Jevtana looks less promising now that it has competition.
Sally, in her insightful post on Pharma Strategy Blog, also notes a possible impact on sipuleucel-T (Provenge) from Dendreon, which is $93K for three infusions. It’s hard not to see some off-label usage from urologists given that phase III trials for use of abiraterone in the pre-chemotherapy setting are already enrolled.
The prostate cancer market is currently a very dynamic and competitive one. With more new drugs on the horizon that may potentially be improvements on abiraterone acetate e.g. MDV3100 and ARN-509, it’s an exciting market to watch.
Sally Church has a number of posts on Pharma Strategy Blog that discuss the science and pharma marketing strategy for prostate cancer new products.