New Leukemia Drug Tops the Charts With a $178,000 Price Tag

Roxanne Nelson

December 18, 2014

The cost of cancer drugs has already been grabbing headlines, and the price tag attached to a newly approved agent is bound to continue fanning the flames.

Amgen has just announced that blinatumomab (Blincyto) will cost about $178,000, making it one of the most expensive oncology drugs on the market.

In a report from Reuters , an Amgen spokeswoman said the price reflected two courses of treatment, at $89,000 per cycle.

"We believe the price reflects the significant clinical, economic and humanistic value of the product to patients and the healthcare system, for an ultra-orphan population with a dramatic impact on a serious illness," Amgen told Reuters in a statement.

Blinatumomab received approval on December 3 from the US Food and Drug Administration for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL). With this approval, blinatumomab became the first drug in a novel class of drugs known as bispecific T-cell engagers to enter the market. It is designed to direct cytotoxic T-cells to CD19-expressing cancer cells. CD19 is a protein expressed on the surface of B-cell-derived ALLs and non-Hodgkin's lymphomas.

The accelerated approval was based on the results of Amgen's '211 trial, a phase 2, multicenter, single-arm, open-label study that included 185 patients with Ph- relapsed or refractory B-cell precursor ALL. The results showed that 41.6% (77/185) achieved complete remission or complete remission with partial hematologic recovery within two treatment cycles. The majority of responses (81% [62/77]) occurred within the first cycle of treatment. Among patients who achieved a remission, 39% went on to receive a stem cell transplant while 75.3% (58/77) achieved minimal residual disease response, a measure of eradication of residual disease at the molecular level.

The ever rising cost of cancer drugs was the subject of a special symposium at the recent annual meeting of the American Society of Hematology, where it was noted that the price of oncologic agents has increased 10-fold in the past decade. Hagop M. Kantarjian, MD, professor, department of leukemia, University of Texas MD Anderson Cancer Center, Houston, and a vocal critic of high drug prices, noted during the symposium that three drugs for chronic myelogenous leukemia (CML) came on the market in 2012 with a price tag of $100,000 a year. In addition, the price of imatinib (Glivec, Novartis) jumped from $28,000 to $92,000 during the past decade.

And these prices, Dr Kantarjian had emphasized, are not just for CML. "They are across the board."

Last year Dr Kantarjian and 120 other leukemia experts voiced their growing concern over the rising cost of drugs and the detrimental impact it might be having on patients.

ALL is a relatively rare disease, with an estimated 6020 cases diagnosed in 2014, almost half of them children, according to the National Cancer Institute. Of this group, about 1400 will die of their disease.

"The overall price of Blincyto is definitely on the high side for cancer drugs," Michael Yee, an analyst with RBC Capital Markets, said in the Reuters report. But he also noted that this price was not surprising "given the drug's impressive effectiveness and that only about 1,000 Americans who had failed previous therapy would be eligible to take it."

He also estimated that drug sales might be about $100 million for ALL, based on use by half of all eligible patients.

Amgen acquired blinatumomab when it purchased the biotechnology company Micromet in 2012, for $1.16 billion. At the time of the acquisition, blinatumomab was under investigation in five clinical trials.

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