Things are looking up for our European readers. It must be frustrating for people outside of the United States to read this blog and learn about the many advances we now have in the US which are not available to them.
The good news is that Sanofi has just launched Jevtana (cabazitaxel) in the UK men with metastatic hormone-refractory prostate cancer (mHRPC), in combination with prednisone, whose cancer has progressed despite treatment with standard chemotherapy agent docetaxel. Jevtana actually received EMA approval in March.
The EMA approved Jevtana based on phase III results from the TOPIC trial, which showed Jevtana significantly extended overall survival (OS) in men with mHRPC by 2.4 months (15.1 months median OS versus 12.7 months in the control arm). It also doubled the median time before the disease progressed compared with chemotherapy drug mitoxantrone (2.8 months versus 1.4 months).
Currently, in Europe men with mHRPC have a poor prognosis.
Now, like the men in the U.S. they will have one more option to fight this disease. Along with this great news is that the US biotech firm Dendreon is planning to also file for the approval of Provenge, also for mHRPC, in Europe later this year.
Provenge, a vaccine that fights advanced prostate cancer, received its US approval last year after its pivotal phase III IMPACT trial showed Provenge extended median survival by 4.1 months when compared to control (25.8 months versus 21.7 months) and reduced the risk of death by 22.5 per cent.
There are some serious questions surrounding the price of both these drugs. Both of them will need to pass muster with NICE, a task they might not be able to win.
Joel T Nowak, M.A., M.S.W.