U.S. FDA approves Novartis’ leukemia treatment

The U.S. Food and Drug Administration approved Novartis AG’s Rydapt as an initial treatment for acute myeloid leukemia (AML) as well as certain other blood disorders, the agency said on Friday.

AML is a cancer that originates in the bone marrow and progresses rapidly, resulting in an abnormal increase in white blood cells.

Rydapt is approved to be used along with chemotherapy to treat adults newly diagnosed with AML and carrying a specific genetic mutation called FLT3, the FDA said. It is to be used along with a companion diagnostic designed to detect the mutation.

Data has shown that using Rydapt as part of the treatment regimen for FLT3-mutated AML patients resulted in a 23 percent reduction in the risk of death, Novartis said.

Rydapt will be available from Monday, with the price depending on the indication and the dose, said Julie Masow, a spokeswoman for the Swiss drugmaker.

The U.S. list price for AML patients is $7,495 for a 14-day treatment duration and $14,990 for a 28-day duration, Masow said.

In a late-stage trial on AML patients, the median duration of therapy (50 mg administered twice a day) was 42 days, implying a list price of $22,485, Masow added.

About 21,380 new cases of AML will be diagnosed in 2017 and some 10,590 patients will succumb to the disease this year, according to estimates by the American Cancer Society.

Rydapt was also approved to treat adults with certain rare blood disorders, including aggressive systemic mastocytosis (ASM) and mast cell leukemia, the FDA said.

The U.S. list price for ASM patients is $32,121 for a 30-day treatment duration. The median duration of therapy (100 mg administered twice a day) in clinical trials was 11.4 months, Masow said.

The list price of a drug is not necessarily what patients actually pay. Their ‘out-of-pocket’ cost is based on their individual healthcare insurance plans and duration of treatment.

(Reporting by Natalie Grover in Bengaluru; Editing by Savio D’Souza)