05April14 IMPORTANT NEWS - Zytiga (Abiraterone) is now approved by TGA for "pre-chemo" metastatic castration resistant prostate cancer (mCRP) patients. Yet they still have to pay a small fortune for this drug that has now been accepted as an effective, low risk treatment and often preferable to chemotherapy. This is because it has not yet been recommended for a PBS subsidy by the PBAC. The new Minister for Health is urged to fix this so that several thousand Australian men might live longer without pain or the ill-effects of chemotherapy.
(Please sign my petition to the Minister at http://chn.ge/QsuSHc )
Here is a very brief summary of the Current TGA Regulatory Status of Abiraterone. (The following are key brief excerpts from the original document¹ which has has 31 pages - see: http://www.tga.gov.au/pdf/auspar/auspar-abiraterone-acetate-140122.pdf ) (There is some highlighting of significant words).
"The product received initial Australian Register of Therapeutic Goods (ARTG) Registration on
27 February 2012."
"Clinical findings (a summary) ...
The Overall Survival (OS) and Radiographic Progression-Free Survival (rPFS) data are supported by convincing results on the secondary endpoints, particularly those relating to the initiation of cytotoxic chemotherapy and opiate analgesia. The other endpoints suggest that abiraterone is likely to be also associated with maintenance of functional status/quality of life.
Overall the data from the pivotal study are considered to provide convincing evidence of the efficacy of abiraterone in chemotherapy-naïve patients with mCRPC. ...
The safety profile of the drug appears more favourable than that of taxane chemotherapy. ... "
"Benefit-risk assessment -
First round assessment of benefits
The benefits of abiraterone in the proposed usage are:
• A decreased risk of disease progression as assessed by bone scan/magnetic resonance imaging (MRI)/computed tomography (CT);
• A delay in the need for chemotherapy and opiate analgesia;
• Maintenance of functional status/quality of life.
First round assessment of benefit-risk balance
The benefit-risk balance of abiraterone, given the proposed usage, was considered to be favourable."
"First round recommendation regarding authorisation
It was recommended that the application be approved. ... restriction (in symptomatic patients in whom chemotherapy is not yet clinically indicated ) seems unnecessary since the risks of chemotherapy are likely to exceed the benefits in asymptomatic or mildly symptomatic patients and therefore chemotherapy is unlikely to be clinically indicated.
The benefit-risk balance of abiraterone in the proposed indication was considered to be positive."
"Indications ... the TGA Clinical Evaluator’s and TGA Delegate's recommendations to approve abiraterone for the extended indication (the sponsor agreed) (were):
“ZYTIGA is indicated with prednisone or prednisolone for the treatment of patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mCRPC):
• who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) or
• who have received prior chemotherapy containing a taxane.” ...
"Janssen (the manufacturer) concurred with the Clinical Evaluator’s and Delegate’s assessment that efficacy has been established in the proposed indication. The EU, whose guidelines TGA adopts, also agreed that efficacy had been established as evidenced by their approving of the extension of indications. The new indication has also been approved in the
, USA and Canada . New Zealand
The safety profile in Study COU–AA-302 (the definitive research study reported in N Engl J Med 2013; 368:138-148 / http://www.nejm.org/toc/nejm/368/2/ ) was consistent with abiraterone’s well established favourable toxicity profile, especially when compared to chemotherapy. For a patient with incurable mCRPC, treatment with an oral medication as an outpatient, without the side effects of cytotoxic chemotherapy, is clinically meaningful in the context of the limited available treatment options."
Based on a review of quality, safety and efficacy, TGA approved the registration of Zytiga/Janssen Abiraterone tablets (250 mg abiraterone acetate) for oral administration, indicated for (additional indication):
Zytiga is indicated with prednisone or prednisolone for the treatment of patients with metastatic castration resistant prostate cancer (mCRP) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT).10F11"
¹ EXTRACTED from SOURCE Document (See the full text in the following):
"AusPAR Zytiga Abiraterone acetate Janssen-Cilag Pty Ltd PM-2012-02706-3-4 Final
22 January 2014"
Therapeutic Goods Administration
Phone: 1800 020 653
Fax: 02 6232 8605