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

Study recalculates costs of combination vaccines

Apr 17, 2014

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

Apr 17, 2014

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

User comments