Marqibo approved for rare leukemia

(HealthDay) -- Marqibo (vincristine sulfate liposome injection) has been approved by the U.S. Food and Drug Administration to treat adults with a rare form of blood and bone marrow cancer, Philadelphia chromosome negative acute lymphoblastic leukemia, abbreviated ALL.

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

ALL is most-often diagnosed in children. The estimates that 6,050 people will be diagnosed this year with the disease, 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 , 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

Marqibo approved for ph- acute lymphoblastic leukemia

Aug 10, 2012

(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 ...

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.

Recommended for you

Same cancer, different time zone

10 hours ago

Just as no two people possess the same genetic makeup, a recent study has shown that no two single tumor cells in breast cancer patients have an identical genome.

Brazilian researchers identify RNA that regulates cell death

15 hours ago

Researchers from the University of São Paulo (USP) have identified an RNA known as INXS that, although containing no instructions for the production of a protein, modulates the action of an important gene in the process ...

User comments