Zeneca Drug Wins FDA Nod to Reduce Chance of Cancer (Update3)
Bloomberg News
October 29, 1998, 5:03 p.m. ET
Zeneca Drug Wins FDA Nod to Reduce Chance of Cancer (Update3)
(Adds company, activist group comment.)
London, Oct. 29 (Bloomberg) -- Zeneca Group Plc, the
world's second-biggest maker of cancer drugs, won U.S. approval
to sell the first drug for reducing the risk of breast cancer.
The action by the U.S. Food and Drug Administration means
the company's tamoxifen drug, already sold under the brand name
Nolvadex as a treatment for breast cancer, can now be promoted
for its effect in reducing the risk of developing the disease.
The drug, which Zeneca will co-promote with its partner Roche
Holding AG for the expanded use, had about $500 million in sales
last year.
''This is a very important option that's being provided to
women today,'' said Michael Friedman, who has served as acting
FDA commissioner. Breast cancer makes up nearly one-third of all
cancers among women and is the second leading cause of cancer
death, according to government officials.
Approval of the expanded use for the drug is also good news
for Pomona, New York-based Barr Laboratories Inc., which sells a
generic version. Bruce Downey, president, chairman and chief
executive of Barr told the Bloomberg Forum that the approval
offers a ''tremendous business opportunity.''
American depositary receipts of U.K.-based Zeneca rose 1 5/8
to 38 1/2, while Barr shares rose 3 to 33 1/2.
No Prevention Claim
The FDA's approval doesn't allow Zeneca to use the word
''prevent'' in its label. Instead, the agency approved labeling
that says the drug can be used ''for reducing the incidence of
breast cancer'' in women at high risk for the disease.
An FDA advisory panel in September, while backing the use of
tamoxifen in healthy women at high risk, stopped short of
endorsing a ''prevention'' claim for the drug. Panel members said
studies have not gone on long enough to demonstrate that the drug
prevents breast cancer for a lifetime.
Specific wording in the label can have a big impact on how
doctors and patients view the drug and how it can be advertised.
Women's health advocates at the advisory panel meeting argued
against allowing the company to use ''prevent,'' saying it would
spur inappropriate prescriptions.
Company spokeswoman Mary Lynn Carver, however, said the
company is satisfied.
''It's almost semantics at this point whether it's 'prevent'
or 'reduction of incidence,''' Carver said. ''It's consistent
with what we've seen in research on women, and physicians
understand that.''
Carver said the new label is being printed and will be
available on the Internet tomorrow and out to doctors next week.
Side Effects
The sales benefit from the newly approved use may be limited
and should be gradual, according to some analysts.
''The question is the safety profile of tamoxifen,'' said
Sergio Traversa, an analyst at Mehta Partners. ''I don't think it
will allow very large use of the drug.''
Indeed, the FDA cautioned that the drug has serious side
effects and shouldn't be prescribed lightly. There's evidence
that women who take the drug may be at higher risk of a different
type of cancer, of the uterine lining, and dangerous blood clots.
''A woman and her healthcare provider need to make a very
careful assessment,'' Friedman said. ''There are demonstrable
benefits. There are also demonstrable risks.''
In addition, not all women benefit from the treatment, he
said.
The FDA approved the new use of Zeneca's drug in healthy,
high-risk women based on the findings of a landmark study
released in April.
The study of more than 13,000 women found that the drug
could reduce breast cancer rates in cancer-prone women by 45
percent compared to high-risk women who took no drug.
It was the first study to suggest that any attempt to reduce
the rate of breast cancer -- including lifestyle changes, diet or
drugs -- could have a beneficial effect. The cause of breast
cancer, one of the leading killers of women, is largely unknown.
Questions
Not everyone was pleased by today's approval. The National
Women's Health Network put out a statement today questioning the
approval.
''The decision was based on short-term results, which have
not been confirmed by other studies,'' said Cynthia Pearson,
executive director of the group. ''The results on healthy women
only show a short-term delay for women at high risk of breast
cancer, and no benefit in terms of saving lives.''
Women in the study will continue to be followed, and future
studies should answer more questions about the drug's effects,
Friedman said. The FDA believes that Zeneca is committed to
making sure that the drug's benefits and risks -- and the need
for a sophisticated evaluation of patients -- are clearly
communicated, he added.
Eli Lilly & Co. is also studying its drug Evista, currently
approved for use in preventing osteoporosis, for its anti-cancer
benefits. So far, the drug shows promise, Traversa said.
''I've seen the data on the cancer and it looks just
great,'' he said. ''And the safety profile looks better'' than
the one for tamoxifen, he said. If Lilly can prove that its drug
is safer than tamoxifen, ''Evista will have a clear advantage,''
he said.
Shares of Indianapolis-based Lilly rose 2 15/16 to 80 1/4.
--Kristin Jensen in Washington (202) 624-1843 and Jim Finkle in |
