Tykerb - Taking Cancer Drug With Food May Cut Costs
- From: J <nexsw@nvalid,anon>
- Date: Tue, 17 Jul 2007 19:22:45 -0400
<
http://www.forbes.com/forbeslife/health/feeds/hscout/2007/07/17/hscout606467.html
Taking Cancer Drug With Food May Cut Costs
07.17.07, 12:00 AM ET
TUESDAY, July 17 (HealthDay News) -- Taking a pricey breast cancer drug
called lapatinib (Tykerb) with food rather than on an empty stomach may
improve its absorption by the body -- lowering the doses needed and
greatly cutting costs for patients, a new study shows.
In a commentary published in the Aug. 10 issue of the Journal of Clinical
Oncology, Drs. Mark Ratain and Ezra Cohen, of the University of Chicago,
suggest that taking the recently approved medication with food --
particularly high-fat food -- cuts the dosage needed by at least 60
percent.
Ratain -- a professor of medicine and associate director for clinical
sciences in UC's Cancer Research Center -- joined Cohen (from the
hematology/oncology section of UC's department of medicine) to highlight
the findings of a study presented in March at the American Society for
Clinical Pharmacology and Therapeutics.
The study, which neither Ratain or Cohen was involved in, revealed that
500 milligrams of Tykerb taken with food appears to be as effective as
1,250 milligrams of the drug taken on an empty stomach, the current
prescription protocol.
"What we have here is this unique situation where patients are shelling
out more than they need to take a drug in a suboptimal manner," said
Ratain.
The current regimen of five 250 milligram tablets per day, taken on an
empty stomach, costs about $2,900 per month. But simply taking the pills
with food could save the patient about $1,740 per month in drug expenses,
a real "value meal" for patients, according to the experts.
Both Ratain and Cohen cautioned that physicians and patients should not
alter Tykerb treatment protocols until further research substantiates
these findings.
Tykerb was approved for use against breast cancer by the U.S. Food and
Drug Administration in March of this year. The oral tablet was developed
by the pharmaceutical company GlaxoSmithKline (GSK) for patients battling
a specific type of advanced-stage breast cancer, in which HER2 -- a
protein that promotes tumor growth -- is expressed.
According to the American Cancer Society, every year approximately 180,000
American women are diagnosed with breast cancer. Annually, upwards of
10,000 women are projected to die from the advanced stage, HER2-positive
version of the disease.
The new treatment was approved for use in combination with another
medication known as capecitabine (or Xeloda), for cases in which a range
of other drugs, such as Herceptin, have ceased to be effective.
According to the FDA, Tykerb inhibits tumor growth by going inside cells
containing the HER2 protein and blocking signals that promote tumor
growth. In contrast, older drugs such as Herceptin have larger molecular
structures that target the outside of the cell.
The FDA approval of Tykerb was based on the results of a study involving
approximately 400 breast cancer patients with advanced-stage HER2 disease.
That study revealed that women who took Tykerb in combination with
capecitabine were significantly more likely to respond positively to
treatment and to experience a delay in tumor growth. The ultimate impact
Tykerb may have on long-term survival was still unknown at the time of
approval.
As is standard procedure with all new drug approvals, the FDA worked with
the drug's manufacturer to compose the instruction labeling accompanying
Tykerb.
As currently worded, physicians and patients are clearly informed that the
medication should be taken on an empty stomach, in light of the fact that
all the study patients consuming Tykerb did take the drug without food.
However, another section of the labeling material notes that absorption of
the drug is boosted when ingested with food.
Ratain said this kind of confusion happens when "getting things done
quickly is considered more important than getting things done right."
"Here's the problem: Since the drug company didn't do their trials with
food, they can not recommend that their drug be given with food," he said.
"I think if the company knew before they started their trial that food
would help absorption, there's no question they would have done the study
with food. But they wanted to get the study started quickly, and they
guessed wrong."
"So," concludes Ratain, "they had two choices: have the drug approved by
the FDA as they had tested it in their trials, or delay the drug until
they do new testing with food. And this sort of boxes them into a corner,
because the market expectations for this drug is about a billion dollars a
year in sales, and they want to get it out there."
"So, the bottom line is that, in the end, the label in one part says take
it fasting, and in another place, it says the concentration and absorption
in the blood is markedly increased if taken with food," Ratain noted. "The
remedy is potentially to take a lower dose with food, which results in a
significantly lower cost to the patient and/or their payers."
Ratain emphasized that Tykerb's interaction with food must now undergo
further study before it can definitively be said that the current labeling
instructions should be altered. However, he pointed out that he is not
aware of any current plans on the part of GSK or a third party to conduct
such a study.
Meanwhile, Ratain said that he and his colleague Cohen simply want to draw
attention to a clear labeling discrepancy with major financial
implications for breast cancer patients -- one that he believes might very
well have slipped through the cracks in the complex world of oncology
treatment.
Dr. David Flockhart is director of the division of clinical pharmacology
at Indiana University School of Medicine in Indianapolis. He said he's
inclined to agree that Ratain and Cohen have identified a hidden cost
saving for patients.
"I think Ratain's probably right," said Flockhart. "Drugs are usually
studied for concentration effects on fasting volunteers. This is routine,
because it's very hard to predict how food may speed up or bind with a
drug and alter absorption. So, the drug company did what they would
normally do. But there happens to be a nice little accident here that
could benefit patients."
"Of course, they're calling for more studies," he noted. "As is needed.
Meanwhile, because tons of labels don't have perfect instructions in them,
doctors will try to do what they always do: use the best information they
have. And doctors may want to consider this new information," Flockhart
said.
.
- Prev by Date: Lab Test to Detect Metastatic Breast Cancer
- Next by Date: July 2007 monthly follow up: "Is melanoma simply a vitamin D deficiency cancer?"
- Previous by thread: Lab Test to Detect Metastatic Breast Cancer
- Next by thread: July 2007 monthly follow up: "Is melanoma simply a vitamin D deficiency cancer?"
- Index(es):
Relevant Pages
|
|
