FDA Approves Pfizer's Leukemia Drug
September 01 2017 - 5:04PM
Dow Jones News
By Peter Loftus
Pfizer Inc. is bringing back a cancer drug it pulled from the
U.S. market over safety concerns in 2010 -- but the second
iteration carries a higher cost, in the latest sign of the
industry's pricing power.
Mylotarg, which treats a form of leukemia, will cost $24,600 per
patient for an average course of treatment, Pfizer said Friday
after the Food and Drug Administration approved the product's
comeback. Pfizer says most patients will receive only one course.
The new price is 58% higher than the $15,522 cost when the drug was
pulled from the market in 2010.
Drugmakers have taken heat from politicians, patients and health
insurers for charging high prices for new drugs and raising prices
of older drugs in recent years. This week, the FDA approved a
pioneering new Novartis AG leukemia treatment that costs $475,000
per patient, which some critics said was excessive but which the
company defended as a responsible price in light of the treatment's
benefits.
Pfizer says the new price for the resurrected Mylotarg doesn't
look as steep once inflation is factored in. Accounting for average
annual U.S. medical-price inflation of about 3%, the 2010 price
would be about $19,128 in today's dollars, Pfizer said. Applying a
higher rate of average drug-price inflation means the 2010 price
would be about $30,252 today, Pfizer spokeswoman Sally Beatty
said.
Ms. Beatty said the company arrived at the new price after
consulting with doctors, insurers and patients to assess the drug's
clinical and economic benefits. "Based on clinical data and
real-world evidence, and support from oncologists, we believe
Mylotarg has the potential to provide meaningful improvement to the
majority of patients with AML," she said.
The FDA first approved Mylotarg in 2000 to treat patients age 60
and older with a type of acute myeloid leukemia, a particularly
aggressive form of blood cancer. The American Cancer Society
estimates there are about 21,380 new cases of AML annually in the
U.S., and about 10,590 deaths from the disease.
After the drug's 2000 approval, additional patient studies
failed to confirm its efficacy, and revealed an elevated risk of
death of patients early in treatment. The FDA requested that Pfizer
stop selling the drug in 2010.
After the withdrawal, independent researchers tested different
doses and other ways to make Mylotarg safer and more effective,
with Pfizer providing the drug for testing purposes, the company
said. The results, which showed the drug improved certain measures
of survival and induced remission in some patients, led to Pfizer's
application to bring the drug back to market.
The FDA on Friday approved a lower dose than the first version
of Mylotarg, a different dosing schedule and in a slightly
different patient population that includes pediatric patients.
One study of the new Mylotarg showed that adding it to
chemotherapy helped newly diagnosed AML patients live an average of
17.3 months without complications, relapse or death from start of
treatment, versus 9.5 months for chemotherapy alone, the FDA said.
Another study found that Mylotarg, given alone, prolonged median
overall survival to 4.9 months versus 3.6 months for certain older
treatments, the FDA said.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
September 01, 2017 16:49 ET (20:49 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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