Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘cabazitaxel’

The challenge of prostate cancer drug approval versus reimbursement

IMG 7619 300x224 The challenge of prostate cancer drug approval versus reimbursement

Scenes from EAU - Arc de Triomphe

Here at the European Association of Urology (EAU) congress in Paris, there are some interesting debates amongst delegates attending the meeting regarding new therapies either recently – or about to be approved – for castrate-resistant prostate cancer (CRPC).

For example:

  1. How should abiraterone and MDV3100 be sequenced pre or post chemotherapy?
  2. Would combining the two drugs post chemo be a better strategy that leads to superior outcomes?
  3. Where does chemotherapy fit into this emerging paradigm?  Do we need chemotherapy in an new era of oral therapies?  If yes, which patients should be considered eligible?
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Update on new data in prostate cancer

The interview with Dr Charles Sawyers from Memorial-Sloan Kettering recently, talking about his role in Medivation’s MDV3100, turned out to be rather good timing.  On Friday, Medivation announced their 1Q earnings and clinical progress.

logo1 Update on new data in prostate cancerThe big news is that aside from the ongoing phase III trials in castrate-resistant prostrate cancer (CRPC) before (PREVAIL) and after failure of docetaxel (AFFIRM), the company are seeking to explore the use of MDV3100 earlier in the disease.  This makes a lot of sense, both clinically and strategically.  A phase II trial is already open in the pre-chemotherapy setting, comparing MDV3100 to bicalutamide (TERRAIN).

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Two new cancer drugs approved – cabazitaxel and nilotinib

Yesterday brought two new approvals in a day from the FDA in completely different cancer types.

In the morning, sanofi-aventis' cabazitaxel (Jevtana) was approved in castrate-resistant prostate cancer after failure of docetaxel (Taxotere) several months ahead of schedule.  This approval comes hot on the heels of Dendreon's sipuleucel-T (Provenge) in asymtomatic metastatic prostate cancer last month.

What this means is that once androgen ablation therapies stop working, there are three new treatment options for men with prostate cancer, none of which compete with each other, with the possible exception of the chemotherapies, since docetaxel is often given in second-line in men who previously responded well and have had a treatment break.  It will be interesting to see if this approach continues or if oncologists will prefer cabazitaxel in those with a good performance status.

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#AUA2010: The beginning of a new era for prostate cancer?

Past American Urological Association (AUA) meetings have seen a lot of same old, same old with very little that is new in the way of truly innovative and exciting new developments.  In many ways, prostate cancer is the male equivalent of ovarian cancer, with pharma companies considering it after the breast, lung and colorectal cancers, despite prostate cancer being fairly large in terms in epidemiology, from a pure numbers perspective.

Why is this?

Firstly, we need to consider the natural course of the disease, which unlike breast and lung cancers, is fairly indolent.  Men diagnosed early with prostate cancer can live for 10-15 years, often with long periods of watchful waiting, making adjuvant trials necessarily long ones.

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American Urology Association AUA 2010 annual meeting

On Friday, I'm heading off to the annual American Urology Association (AUA) meeting in San Francisco and looking forward to catching up on the hot topics in prostate and renal cancers.  

 American Urology Association AUA 2010 annual meetingIt promises to be a good meeting this year with lots of new data expected from a number of marketed products, newly approved products and of course, products in development.

I'll be tweeting snippets from the meeting under the hashtag #AUA2010 as some attendees are already actively using that one.  Unfortunately, #AUA already seems to be used for something else, which is a shame as those extra 4 characters make a huge difference on Twitter!

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