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WHAT IS HAPPENING WITH THE NEW DRUGS


Euan

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Cabazitaxel (Jevtana®),

FDA approved June 17, 2010 – US$8000 per vial typically 6 vials used.

The median overall survival for patients receiving the Jevtana regimen was 15.1 months compared with 12.7 months for those who received the mitoxantrone regimen.

Finally recommended for PBS listing in March 2012 after failing in July 2011 and Nov 2011. PBS listing began on 1 Aug 2012 at a cost of approx A$5900 per vial [jm: but at a maximum cost to Australian men of $35.40] and with the following restrictions:

“Treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a WHO performance status of 2 or less.”

Abiraterone acetate (Zytiga®)

FDA approved April 28, 2011. A CYP17 inhibitor (blocks production of testosterone) costing US$5000 per month. Patients who received the Zytiga and prednisone combination had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone combination.

First request for PBS listing in November 2011 declined but March 2011 outcome was positive.

“Recommended on a cost-minimisation basis with cabazitaxel. The PBAC noted that abiraterone has a better safety profile and is more convenient to administer (oral administration) than cabazitaxel.” [jm: The company subsequently withdrew its application for listing on the PBS because it found the conditions set by the PBAC unacceptable. So the drug was then not scheduled to be listed in the PBS.]

However resubmitted to July 2012. Approved by the PBAC [jm: The company subsequently withdrew its application for listing on the PBS because it found the conditions set by the PBAC unacceptable. So the drug was then not scheduled to be listed in the PBS.] At the Nov 2012 PBAC meeting it has been approved again with minimal changes. [jm: We await the company's response.]

Note: The net financial cost to the PBS was considered uncertain because of the potential of extended use beyond disease progression given the safety profile and ease of administration of abiraterone.

Enzalutamide (Xtandi®) formerly MDV3100

On August 31, 2012, the U. S. Food and Drug Administration approved the androgen receptor-signalling inhibitor enzalutamide for treatment of men who have progressed following treatment with docetaxel. Cost US$7,500 dollars per month.

In the phase 3 trial the median overall survival was 18.4 and 13.6 months (4.8 months increase) in the enzalutamide and placebo arms, respectively. However, seizures occurred in 0.9% of patients on enzalutamide even thought patients with a known history of seizure were excluded from the clinical trial.

Choline C 11 PET

The U.S. Food and Drug Administration on 12 Sept 2012 approved the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer.

Radium-223 chloride (Alpharadin®)

Alpharadin was granted fast-track approval by the FDA in June 2012. The median overall survival was 14.9 months for Alpharadin and 11.3 months for placebo (3.6 months increase)

Alpharadin uses alpha radiation from radium-233 decay to destroy cancer cells. Radium-223 naturally targets bone metastases due to its calcium-mimicking properties. Alpha radiation has a much shorter range than current beta/gamma radiation - it causes less damage to surrounding tissue, especially bone marrow.

Abiraterone acetate (Zytiga®) - expanded

On December 10, 2012, the U. S. Food and Drug Administration approved an expanded indication for abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (before chemotherapy). The median radiographic progression-free survival was 16.5 months with abiraterone-prednisone and 8.3 months with prednisone alone.

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