FDA Approves Pfizer's Leukemia Drug

By Peter LoftusFeaturesDow Jones Newswires

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.

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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)