Avastin Showdown: The Fight for a Cancer Fighter

03. Oct, 2010 0 Comments

Avastin Showdown: The Fight for a Cancer Fighter
By Peter J. Pitts
One more day – or week, or month, or perhaps even a year. It may not seem
like much time, but patients with incurable cancer know better. For
Christi Turnage of Mississippi, who lives with stage IV breast cancer, it
means seeing her daughter start kindergarten, celebrating her 27th wedding
anniversary, and watching her sons graduate from college.

Her family and her oncologist credit her quality of life for the past two
years to the drug Avastin, a biologic that combats cancer by cutting off
the blood supply to tumors. But advanced breast cancer patients like
Turnage have been forced to spend precious time battling something else:
the possibility that federal regulators will vote to remove approval of
Avastin for their treatment.

If officials with the U.S. Food and Drug Administration are wise, they
will overrule the agency’s cancer-drug advisory panel, which voted 12-to-1
in July to recommend denying a valuable clinical option to advanced breast
cancer patients. According to the Department of Health and Human Services,
an estimated 40,000 women die from breast cancer each year.

The panel concluded that the costly drug doesn’t eke out enough extra
lifetime among breast cancer patients to justify its use and risks. This
ignores all the “super responders” — the patients who reap significant
benefits from Avastin. Scientists have no way of identifying these people
in advance, and they could be devastated if they are denied the medicine.

”This is not a worthless drug by any means,” Eric Winer, director of the
Breast Oncology Center at the Dana-Farber Cancer Institute in Boston.
“There is almost certainly a group of women who get a big benefit.”

Indeed, the Susan G. Komen for the Cure and Ovarian Cancer National
Alliance – recently sent a joint letter to the FDA urging the government
to keep it as a choice best made by a woman and her doctor.

The groups also warned that if the FDA de-lists Avastin for breast cancer,
it would only discourage future drug development.

Two years ago, the FDA fast-tracked approval of Avastin for metastatic
breast cancer two years ago, and since then it has been prescribed to
about 17,500 women a year with the disease. The drug, which earned FDA
approval for the treatment of colon, lung, kidney and brain cancer, is the
> world’s best-selling cancer drug.

A clinical trial that took place from December 2001 and May 2004 found
that Avastin boosted the amount of time that breast cancer patients lived
without the disease spreading or worsening. The drug in combination with
chemotherapy delayed tumor growth for about 11 months, which was more than
five months longer than chemo alone. Follow-up studies indicated a less
robust response, yet still found an average delay in tumor growth to
between one and three months.

But even if Avastin does not, “on average,” extend life for breast cancer
patients, that “average” is composed of patients who respond in
dramatically different ways –including some like Christi Turnage who gain
years.

Another is retired California art teacher Patricia Howard, who reports
that infusions of Avastin every three weeks over the past two years have
shrunk tumors in the lining of her lung and eliminated fluid that hampered
her breathing. Now she enjoys shopping and golf, and describes her life as
“beyond fabulous.”

Serving as a patient representative at the FDA’s last session, Howard
recalled, “One doctor got up during the meeting and said ‘This drug gets
women only to first base and we want a home run.’ I felt like jumping up
and saying I don’t mind just being in the ballgame.”

If the FDA does remove approval of Avastin for breast cancer, doctors
conceivably could write prescriptions for it anyway, going “off label.”
But it’s likely that Medicare and private insurers would not cover the
cost of what is one of the world’s most expensive drugs. Patients could
continue Avastin only if they could afford $8,000 a month out of pocket.

Avastin is a better alternative than the status quo for breast cancer
patients, and can be truly transformative for some. No wonder
Avastin-users are desperately writing letters, circulating petitions and,
like Turnage’s 19-year-old son Josh, posting videos on YouTube
(http://bit.ly/bXlUFA) pleading their case.

Avastin is their last hope. The FDA should make sure it is not their lost
hope.

Peter J. Pitts is President of the Center for Medicine in the Public
Interest and a former FDA Associate Commissioner.