It was approved in the Netherlands on Jan 1st this year. But
I gathered
from my rads onc that it's only given to those who were Her
3+, as it
doesn't work for everyone.
Jacqueline
Anne Holmes writes:
>
>
>
> From: Anne Holmes <aholmes_at_NETSPACE.NET.AU>
Date: Mon Mar 27 2006 -
> 17:35:13 EST
>
>
>
>
> People on BClist may be interested in this - in
Australia we are still
> waiting.
>
> Anne Melbourne 23 March 2006 The cancer medicine
Herceptin has
> been provisionally approved for the treatment of some
women with early
> stage breast cancer.
>
> The announcement was made today by the Medicines and
Medical Devices
> Safety Authority (Medsafe). The provisional consent
limits the use of
> Herceptin to treat women with early breast cancer who
test positive
> for the HER2 gene once they have had surgery and
completed their
> adjuvant (additional) chemotherapy.
>
> Due to concerns that use of Herceptin may be associated
with heart
> damage, the provisional consent also limits the
treatment to those
> women who have a normal heart function before treatment
starts and
> requires women using Herceptin to have their heart
function checked by
> echocardiogram every three months during treatment.
>
> Medsafe's principal technical specialist, Dr Stewart
Jessamine, says
> Medsafe is the first medicines regulatory authority to
assess and
> approve Herceptin as a treatment for primary breast
cancer.
>
> The decision to approve Herceptin follows a positive
recommendation
> from the Medicines Assessment Advisory Committee.
"The decision to
> give provisional consent means that Medsafe and the
committee are
> satisfied that the benefits of treatment outweigh the
risks at this
> stage. This decision has been made on the basis of
limited data, and
> further data examining the overall safety and
effectiveness of
> Herceptin in the long term is required before Herceptin
can be
> considered for full consent," Dr Jessamine says.
>
> As part of the approval process, the Medicines
Assessment Advisory
> Committee considered an interim analysis of clinical
trial results
> including the pivotal HERA study, and other published
data. It
> concluded that treatment with Herceptin significantly
reduced the
> recurrence rate of breast cancer compared to women who
received no
> additional treatment. The HERA study found that after
12 months, the
> recurrence of HER2 breast cancer was reduced by 9%
after treatment
> with Herceptin (86% disease- free on Herceptin +
standard adjuvant
> chemotherapy vs. 77% disease-free following standard
adjuvant
> chemotherapy).
>
> Another study includes a small number of women who have
been followed
> up for up to four years. This study has reported that
treatment with
> Herceptin in addition to standard adjuvant chemotherapy
reduced the
> recurrence of HER2 breast cancer by 18% (85%
disease-free on
> Herceptin+standard adjuvant chemotherapy vs. 67%
disease-free on
> standard adjuvant chemotherapy).
>
> Answering the question about whether preventing breast
cancer
> recurrence also prevents premature death is more
difficult at this
> stage. One study found a 4% increase in survival rates
at four years
> (91% survival of those treated with Herceptin at 4
years compared to
> 87% for those with standard treatment). However this
study examined
> data at four years for less than 200 patients, which
limits our
> confidence in the results. The range of survival rates
from this study
> could be as low as 0.6% increase in survival or as high
as 9%.
> However, the pivotal HERA study showed no significant
difference in
> survival rates for those treated with Herceptin at 2
years follow-up.
>
> In addition to demonstrating benefits, it was noted by
the committee
> that research also demonstrated that use of Herceptin
was associated
> with significant side effects. Of most concern was the
finding that up
> to 3% of women developed severe heart failure while
being treated with
> Herceptin.
>
> "Due to these concerns the committee recommended
that careful
> monitoring of heart function be undertaken as a
condition of the
> provisional approval", Dr Jessamine says.
>
> "Before the committee is able to consider an
application for full
> approval of Herceptin the manufacturer has been asked
to provide the
> committee with further safety and efficacy data as it
becomes
> available, including data on long-term survival after
treatment."
>
> The Medicines Assessment Advisory Committee (MAAC) is a
Ministerial
> advisory committee consisting of clinicians and experts
in a range of
> specialties.
>
> The members of the committee assess data on the safety
and efficacy of
> medicines independently of Medsafe. Dr Jessamine wished
to take this
> opportunity to publicly thank the committee for the
professionalism
> they bring to the task, and the time they invest in
evaluating
> medicines applications.
>
> "I believe that the skills we apply when
considering the safety and
> efficacy of medicines are up there with the rest of the
world, and
> that it is good to see that a small regulator, such as
Medsafe, can in
> the right circumstances be the first to assess and come
to a
> conclusion about the safety of a new medicine, such as
Herceptin."
>
>
>
>
>
>
>
>
------------------------------------------------------------
> This email was sent from Netspace Webmail: http://www.netspace.net.au
>
>
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>
> Received on Mon Mar 27 17:38:28 2006
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