Marqibo approved for ph- acute lymphoblastic leukemia

Marqibo approved for ph- acute lymphoblastic leukemia

(HealthDay) -- Marqibo (vincristine sulfate liposome injection) has been approved by the U.S. Food and Drug Administration to treat adults with Philadelphia chromosome negative acute lymphoblastic leukemia (ALL).

The drug is sanctioned for people whose disease has progressed, despite use of at least two anti-leukemia regimens.

The estimates that 6,050 people will be diagnosed this year with ALL, and 1,440 will die from it, the FDA said Thursday in a news release.

Marqibo was approved as an orphan drug, designed to treat a rare disease or condition.

The drug was evaluated in a clinical trial of adults whose disease had relapsed at least twice, despite standard anti-leukemia treatments. The most common side effects reported were constipation, nausea, low blood cell count, fever, nerve damage, fatigue, diarrhea, loss of appetite, and insomnia.

The drug's labeling will include a boxed warning that the drug must only been administered intravenously, and that it could be lethal if administered in another way.

Marqibo is marketed by San Francisco-based Talon Therapeutics.

More information: The FDA has more about this approval.

add to favorites email to friend print save as pdf

Related Stories

Kyprolis approved for multiple myeloma

Jul 20, 2012

(HealthDay) -- Kyprolis (carfilzomib) has been approved by the U.S. Food and Drug Administration to treat certain people with multiple myeloma who have already been given at least two prior therapies.

Afinitor approved for advanced breast cancer

Jul 23, 2012

(HealthDay) -- Afinitor (everolimus) has been approved in combination with the drug exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer, the U.S. Food ...

Perjeta approved for advanced breast cancer

Jun 11, 2012

(HealthDay) -- Perjeta (pertuzumab) has been approved by the U.S. Food and Drug Administration to treat people with HER2-positive late-stage breast cancer, the agency said in a news release.

Myrbetriq approved for overactive bladder

Jun 28, 2012

(HealthDay) -- Myrbetriq (mirabegron) has been approved to treat adults with overactive bladder, a condition affecting some 33 million Americans, the U.S. Food and Drug Administration said Thursday in a news release.

Recommended for you

Discovery helps to spot what makes a good drug

2 hours ago

(Medical Xpress)—A new test developed by researchers from the University of Manchester could revolutionise the discovery of new prescription drugs. The test will help determine which drugs are unlikely to work at an early ...

Merck completes sale of consumer unit to Bayer

19 hours ago

Drugmaker Merck said Wednesday that it completed the sale of its consumer care business, which makes products including Claritin allergy medication and Coppertone sun-care line, to German health care company Bayer for $14.2 ...

Viagra ads target women for first time

Sep 30, 2014

The maker of the world's top-selling erectile dysfunction drug on Tuesday will begin airing the first Viagra TV commercial in America that targets the less-obvious sufferers of the sexual condition: women.

User comments