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 , Canada and 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."
"Outcome
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
Email:
info@tga.gov.au
Phone:
1800 020 653
Fax:
02 6232 8605
http://www.tga.gov.au
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