December 3, 2014 / 6:50 PM / 4 years ago

U.S. FDA approves Amgen leukemia drug ahead of schedule

(Reuters) - U.S. health regulators on Wednesday approved an Amgen Inc drug that helps the immune system fight a rare type of leukemia, more than five months ahead of the expected decision date.

The drug, blinatumomab, which will be sold under the brand name Blincyto, was approved to treat a form of acute lymphoblastic leukemia (ALL) for which there are few treatment options once a patient has relapsed.

The initial approval is for patients whose cancer has returned after treatment or did not respond to previous treatment, such as a stem cell transplant or chemotherapy.

Dr. Anthony Stein, professor of hematology at City of Hope outside Los Angeles who worked on clinical trials of blinatumomab, called the approval “very important” for patients.

“It’s a very promising therapy and there are new trials trying to move the drug into an earlier stage of treatment,” Stein said.

The U.S. Food and Drug Administration had given blinatumomab both its breakthrough designation, used for what it sees as potentially important new medicines, and a priority review, which typically cuts the approval decision time to six months from the normal 10 to 12 months. The action date under the priority review had been May 19, 2015.

“Blincyto is being approved under the FDA’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect ... reasonably likely to predict clinical benefit to patients,” the agency said.

The program provides earlier patient access to promising new drugs while the company conducts further clinical trials to confirm the effectiveness of the medicine.

In a clinical trail used for the approval decision, 32 percent of patients achieved complete remission for nearly seven months after receiving the drug via infusion for four weeks.

“Immunotherapies, especially Blincyto with its unique mechanism of action, are particularly promising for patients with leukemia,” Richard Pazdur, head of FDA evaluation of cancer products, said in a statement.

Blincyto will carry a boxed warning stating that in clinical trials some patients experienced low blood pressure and difficulty breathing at the start of the first treatment or experienced a short period of difficulty with thinking or other side effects in the nervous system.

An estimated 6,020 Americans will be diagnosed with ALL and 1,440 will die from the disease in 2014, according to the National Cancer Institute.

Reporting by Bill Berkrot; Editing by Richard Chang

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