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

Use new meningitis vaccines only for outbreaks

6 hours ago

(AP)—A U.S. panel on Thursday recommended that two new meningitis vaccines only be used for rare outbreaks, resisting tearful pleas to give it routinely to teens and college students.

New antibiotic avycaz approved

10 hours ago

(HealthDay)—The combination antibiotic Avycaz (ceftazidime-avibactam) has been approved by the U.S. Food and Drug Administration to treat adults with complicated infections of the intra-abdominal area or urinary tract, ...

Tagging drugs to fight counterfeit medicines

Feb 25, 2015

The U.S. and other countries are enacting rules to clamp down on the sales of fake pharmaceuticals, which pose a public health threat. But figuring out a system to track and authenticate legitimate drugs still faces significant ...

Watchdog group seeks FDA ban of antifungal tablets

Feb 24, 2015

(AP)—A consumer safety group is calling on the Food and Drug Administration to pull certain antifungal tablets off the market, saying there are safer medicines that do not carry risks of liver damage.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.