Blincyto Patients Demonstrate Leukemia Remission, Amgen Claims

July 23, 2015

Amgen is reporting a “clinically meaningful number” of patients showed complete remission in a Phase 2 study of its pricey drug to treat a rare strain of leukemia.

Blincyto (blinatumomab) was tested on patients with relapsed or refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, or ALL. Many of those in the open-label, single-arm, multicenter study who responded positively to the therapy showed complete remission or complete remission with partial hematological recovery within two treatment cycles, the drugmaker says.

ALL affects about 900 patients in the U.S. who have a median overall survival rate of three to five months, according to an Amgen spokeswoman. The wholesale acquisition cost of Blincyto is $3,178 per vial, which equates to $89,000 per cycle.

Amgen released few other details about the study, including the number of patients involved and the number of patients who saw positive results, stating the data will be submitted for a future medical conference and for publication.

The news is the latest in a series of positive announcements for Blincyto since the drug received breakthrough therapy designation from the FDA a year ago.

Blincyto received FDA approval in December following a clinical trial of 185 patients, 32 percent of whom showed complete remission for 6.7 months. The FDA asked Amgen to conduct additional studies to evaluate the drug’s effect on survival rates.

The FDA requires a boxed warning on Blincyto that patients may experience low blood pressure and difficult breathing due to cytokine release, as well as nervous system difficulties, such as trouble thinking. — John Bechtel