Breast Cancer Halted by Novartis Drug From Easter Island | Cancer ...

Chemotherapy robbed Rachel Midgett
of her hair, appetite and energy as she battled breast cancer
that had spread to her liver. After nine months on Novartis AG (NOVN)?s
Afinitor, she ran a half-marathon in Las Vegas in December.

Midgett, 40, is scheduled to have surgery next month to cut
the tumor from her liver after undergoing a previous operation
to remove her breasts. The procedure could leave her disease-
free for the first time since she was diagnosed in 2009.

?I?m a huge fan of Afinitor, it prolonged my life,?
Midgett said in a telephone interview from her home in Houston.
While on the drug, ?I felt like a normal human being again.?

The medicine, which traces its origins to a bacteria that
lurks in the soil around Easter Island and its mysterious stone
monoliths, won U.S. approval for breast cancer last week. That
green light could give Chief Executive Officer Joe Jimenez a
welcome $1.5 billion sales boost just as some of the company?s
top sellers lose patent protection, including the top-selling
blood pressure pill Diovan and the cancer drug Gleevec.

With Afinitor, Novartis is treading on the toes of
crosstown rival Roche Holding AG (ROG), the biggest seller of cancer
drugs, which lost permission last year to market its blockbuster
Avastin for breast tumors in the U.S. after failing to prove
that the drug extended patients? lives.

Midgett got Afinitor, combined with AstraZeneca Plc (AZN)?s
Arimidex, as part of a clinical trial at MD Anderson Cancer
Center in Houston. Other patients, encouraged by stories like
hers and positive test results, started asking for the drug even
before the Food and Drug Administration cleared it, said
Jennifer Litton, a breast cancer specialist at MD Anderson.

Doctor and Patient

While Litton said she didn?t promote the use of the drug
prior to its regulatory approval, doctors can prescribe
treatments for their patients that are approved for other
diseases. Prior to clearance for breast cancer, Afinitor was
sold in the U.S. for tumors of the kidney and pancreas.

Women whose tumors have spread after initial treatment are
looking for new options after Avastin?s approval for breast
cancer was revoked in November. While Afinitor has yet to
demonstrate it can prolong life, preliminary data showed a trend
toward extended survival.

The Novartis product also comes without some of the
?devastating side effects? of Avastin, according to Litton.
Roche?s medicine was linked to high blood pressure, bleeding,
hemorrhage and heart attacks.

?Not as Sick?

?It?s showing more significant benefit, but it?s also not
making people as sick as some of the other therapies,? she said
in a telephone interview. ?It?s very promising.? Litton was an
investigator in the trial that Novartis used to apply for FDA
approval of Afinitor for breast cancer. She doesn?t hold
Novartis stock and gets no personal compensation from the
company, she said.

Still, taking the drug may have drawbacks. The side effects
patients report from Afinitor, also known by its chemical name
everolimus, can include mouth ulcers, change in taste, and mild
cases of rash, diarrhea, loss of appetite and weight loss, said
Clifford Hudis, chief of the breast cancer medicine service at
Memorial Sloan-Kettering Cancer Center in New York.

?Are the toxicities of everolimus mild enough that it?s
worth it to be on that for a five or six-month delay in the
initiation of chemotherapy?? Hudis said in a telephone
interview. ?That?s the judgment that doctors have to make over
and over again.?

Marshmallow or Whipped Cream

Midgett says she had sores on her tongue at the beginning,
until she started taking the pill encased in a marshmallow.
Other patients told her they favor whipped cream, she said.

After that ?my only side effect was joint pain,? she
said. ?For about 10 or 15 minutes every morning I was wobbling
around because my ankles and feet and knees hurt. My hair grew
back, I didn?t have any bloodwork problems, I didn?t have
fatigue.?

Midgett continues to work as a sales representative for UCB
SA (UCB), selling the Belgian company?s arthritis medicine Cimzia.

European regulators recommended approving Afinitor for
breast cancer last month.

Sales of Afinitor, which climbed 66 percent to $318 million
in the first half, may reap $2.5 billion by 2016, according to
Tim Race, an analyst with Deutsche Bank AG in London. Breast
cancer alone would account for $1.5 billion, Race estimates.

The condition is the biggest cancer killer among women.
About 1.4 million cases are newly diagnosed every year, and
almost 460,000 women die, according to the International Agency
for Research on Cancer in Lyon, France.

Island Bug

The Swiss drugmaker developed Afinitor from a bacteria
first identified in the late 1960s on Easter Island. Researchers
isolated an antifungal agent from the bug in 1975 that became
known as rapamycin, and is sold by Pfizer Inc. (PFE) (PFE) as Rapamune to
prevent the rejection of kidney transplants.

Afinitor is derived from rapamycin, which Novartis gets
from bacteria it grows at a plant in Stein, Switzerland. The
company has sold the drug since 2003 under the brand names
Certican and Zortress for organ transplant patients and since
2009 as Afinitor for kidney cancer.

The drug works by blocking a protein called mTOR that some
cancer cells require to grow and multiply. That can enhance and
prolong the effect of cancer-killing drugs such as Pfizer?s
Aromasin, which belong to a class of treatments called aromatase
inhibitors.

In a clinical trial among 724 women whose cancer had
progressed after hormone therapy, 25 percent of those receiving
a combination of Afinitor and Aromasin died after 18 months,
compared with 32 percent of patients receiving Aromasin alone,
according to data presented at the American Society of Clinical
Oncology?s annual meeting in Chicago in May.

Roche?s Plans

While the test needs to run for longer for the company to
conclude that Afinitor has a survival benefit, the trend is
?pointing in the right direction,? says Deutsche Bank?s Race.

Afinitor also delayed the progression of breast cancer by a
median of 7.8 months compared with 3.2 months among patients
receiving Aromasin alone.

Roche, which sits 2 miles down the Rhine river from
Novartis?s headquarters, hasn?t given up on its own drug Avastin
for breast cancer. Besides selling the medicine for colon, lung,
kidney and brain cancer in the U.S., it plans to start a new
study this year to show the product?s impact on the most common
form of breast tumors.

?We do believe the drug works,? Daniel Grotzky, a Roche
spokesman, said by telephone. Roche is still able to market
Avastin for breast cancer treatment in Europe.

After a year on Afinitor, Midgett?s cancer started growing
again at the end of February. Now she?s on a new trial involving
a combination of Bristol-Myers Squibb Co. (BMY) (BMY)?s Taxol and an
experimental drug from Takeda Pharmaceutical Co. (4502) Midget, who?s
lived three years since her initial diagnosis, says she?s
grateful because the drug prolonged her life already.

?A textbook prognosis for someone like me is two years,?
she says. ?I just feel very blessed that I?ve made it this far.
Every day is a gift.?

To contact the reporter on this story:
Simeon Bennett in Geneva at
sbennett9@bloomberg.net

To contact the editor responsible for this story:
Phil Serafino at
pserafino@bloomberg.net

Article source: http://www.businessweek.com/news/2012-07-22/breast-cancer-halted-by-novartis-drug-from-easter-island

Source: http://cancerkick.com/2012/07/22/breast-cancer-halted-by-novartis-drug-from-easter-island/

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