[Ip-health] Reuters: "Roche breast cancer drug 'unprecedented' in extending lives." But, at a high price

Jamie Love james.love at keionline.org
Sun Sep 28 12:25:55 PDT 2014

This report by Reuters on new evidence about the efficacy of the
combination of two Roche cancer drugs is potentially good news for many
women with metastatic breast cancer.  However, the high price is going to
limit access and create hardships on patients and reimbursement entities.
The Roche says the cost of Herceptin alone is $5,300 per month, while the
cost of the combination of Herceptin and Perjeta will be $5,300 + $5,900
per month, or about $134k per year, as long as you live. (For many
patients, the Roche quotes lowball the costs).

If the Obama Administration was looking out for patients, rather than this
swiss drug company, someone in the administration would say something
critical about charging $134k per year for a breast cancer treatment, and
somebody would take an interest in the access limiting impact of these high



Roche breast cancer drug 'unprecedented' in extending lives

MADRID Sun Sep 28, 2014 11:53am EDT

(Reuters) - A new breast cancer drug from Roche has shown "unprecedented"
benefits in extending lives in a clinical trial and experts urged its
widespread use for women with an aggressive form of the disease.

Patients with a type of breast cancer known as HER2 positive, which makes
up about a quarter of all breast cancers, who were given Perjeta on top of
older medicine Herceptin and chemotherapy lived 15.7 months longer than
those on Herceptin and chemotherapy alone.

That is the longest extension to survival ever seen for a drug studied in
metastatic breast cancer and also an unusually good result for any type of
metastatic cancer, where disease has spread to other parts of the body.

The result is a vindication of combining medicines that fight tumor cells
in a variety of ways.

Both Herceptin and Perjeta are antibodies designed to block the function of
HER2, a protein produced by a cancer-linked gene. Perjeta, also known as
pertuzumab, binds to a different part of the same protein, which makes
combining the two drugs extra effective.

"The results, I think, are phenomenal," lead researcher Sandra Swain from
the Washington Hospital Center told the European Society for Medical
Oncology (ESMO) annual congress in Madrid on Sunday.

"The survival improvement of nearly 16 months ... is unprecedented among
studies of metastatic breast cancer."
Perjeta, which was approved by regulators two years ago, was tested in the
Roche-backed study involving more than 800 women.

Researchers had previously reported the Perjeta drug regimen significantly
extended progression-free survival, or the period of time patients live
without their disease worsening, but the final overall survival data has
taken longer to collect.

The median overall survival time was 56.5 months for those given Perjeta
against the already impressive 40.8 months for patients taking only the
older drugs.

Looking at the study results a different way, the risk of dying was reduced
by 32 percent for women who received the Perjeta regimen compared to those
who got Herceptin and chemotherapy.

While both Perjeta and Herceptin have side effects, including rash,
diarrhea and a potentially adverse impact on heart function, using the two
drugs together did not make these issues any worse.

"I think these data are really compelling," said Eric Van Cutsem of the
University of Leuven, who was not involved in the research. "When you see
in breast cancer such a big change in survival with not a lot of
cardio-toxicities then that is really practice-changing."


Swain and Javier Cortes, another researcher on the study from the Vall
D’Hebron Institute of Oncology in Barcelona, said the results suggested
using Perjeta should now be the standard of care for HER2 positive breast
cancer patients.

A favorable reaction from oncologists will underpin expectations of strong
sales for Perjeta, which analysts currently expect to sell $3.1 billion a
year by 2018, according to consensus forecasts compiled by Thomson Reuters

But it poses a challenge for healthcare providers, since Perjeta and
Herceptin are costly injectable drugs and the multiple-drug regimen
promises to strain budgets.

In the United States, the monthly price of Perjeta is approximately $5,900,
while Herceptin costs around $5,300, a Roche spokeswoman said. Prices in
Europe are lower.

For Roche, Perjeta is an important new product that should help defend its
position in breast cancer, following the success of Herceptin, which was
first approved in 1998.

The company said the latest data would be submitted to regulatory
authorities around the world for inclusion in the prescribing information
for Perjeta.

The Swiss drugmaker also has another related drug called Kadcyla, which is
also being tested in combination with Perjeta. Some analysts believe
Kadcyla's prospects could be curbed if results from that combination are
not better than the impressive findings reported this weekend.

(Editing by David Holmes and Michael Urquhart)

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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