FDA approves Gleevec for children with acute lymphoblastic leukemia

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration has approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated. Children with Ph+ ALL have a genetic abnormality that causes proteins called tyrosine kinases to stimulate the bone marrow to make too many immature white blood cells. This leaves less room for healthy white blood cells needed to fight infection.

Gleevec, a tyrosine kinase inhibitor, blocks the proteins that promote the development of cancerous cells. It should be used in combination with chemotherapy to treat children with Ph+ ALL.

"We are pleased that the number of cancer medications for children are on the rise," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Today's approval is the result of continuous interactions among the FDA, the Children's Oncology Group and the National Cancer Institute to provide new and better treatments to American children with cancer."

Gleevec's safety and effectiveness for this new indication were established in a clinical trial conducted by the Children's Oncology Group, sponsored by the National Cancer Institute. The trial enrolled children and young adults 1 year and older with very high risk ALL, defined as patients with a greater than 45 percent chance of experiencing complications from their disease within five years of treatment. Ninety-two patients with Ph+ ALL were enrolled in the trial and divided into five treatment groups, with each successive group receiving a greater duration of Gleevec treatment in combination with chemotherapy.

Fifty of the Ph+ ALL patients received Gleevec for the longest duration, and 70 percent of these patients did not experience relapse or death within four years (event-free survival). Results also showed patient deaths decreased with increasing duration of Gleevec treatment in combination with chemotherapy.

The most common side effects observed in children with Ph+ ALL treated with Gleevec in combination with chemotherapy included decreased levels of infection-fighting blood cells called neutrophils; decreased levels of blood platelets, which assist in blood clotting; liver toxicity; and infection.

Gleevec was granted accelerated approval in 2001 to treat patients with blast crisis, accelerated phase or chronic phase Ph+ chronic myeloid leukemia (CML) who have failed interferon-alpha therapy. It has since been approved to treat several conditions, most recently regular approval to treat children newly diagnosed with Ph+ CML (2011) and regular approval to treat adults whose Kit (CD117)-positive gastrointestinal stromal tumors (GIST) have been surgically removed (2012).

Gleevec is marketed by East Hanover, N.J.-based Novartis.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Meditation, yoga and vegetarian diet linked to dec…

In a novel controlled clinical trial, participants in a six-day Ayurvedic-based well-being program that featured a vegetarian diet, meditation, yoga and massages experien...

Read more

Abbott to sell Abbott Medical Optics to Johnson …

Abbott (NYSE: ABT) announced today that it will sell Abbott Medical Optics, its vision care business, to Johnson & Johnson for $4.325 billion in cash. Abbott's vision bus...

Read more

Novartis convenes experts to discuss new technolog…

Novartis today opened the 13th International Biotechnology Leadership Camp (BioCamp). Over the course of three days more than 60 selected students from international univ...

Read more

Caffeine and its analogues revert memory deficits …

A study published in the journal Scientific Reports from Nature publishing group, describes the mechanism by which caffeine counteracts age-related cognitive deficits in ...

Read more

Amgen obtains global development and commercial ri…

Amgen (NASDAQ:AMGN) and Boehringer Ingelheim today announced that Amgen has acquired global development and commercial rights from Boehringer Ingelheim for BI 836908 (AMG...

Read more

Vitamin C may boost effectiveness of acute myeloid…

A simple adjustment to patients' therapeutic regimen may improve the effectiveness of the standard epigenetic treatment for myeloid dysplastic syndrome (MDS) and acute my...

Read more

Roche ranked most sustainable healthcare company i…

For the eighth consecutive year, Roche (SIX: RO, ROG; OTCQX: RHHBY) has been recognised as Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life...

Read more

10th European Medical Information and Communicatio…

29 - 30 November 2016, Berlin, Germany The 10th year of the Annual European Medical Information and Communications Conference is a unique meeting organised by medical in...

Read more

Saniona and Boehringer Ingelheim sign collaboratio…

Boehringer Ingelheim, one of the world's 20 leading pharmaceutical companies, and Saniona, a leading biotech company in the field of ion channel drug discovery, have ente...

Read more

Study shows how Chinese medicine kills cancer cell…

Researchers at the University of Adelaide have shown how a complex mix of plant compounds derived from ancient clinical practice in China - a Traditional Chinese Medicine...

Read more

Benralizumab phase III trials show positive result…

Results from pivotal Phase III trials presented at the European Respiratory Society (ERS) International Congress demonstrated that adding benralizumab to standard-of-care...

Read more

Antibody reduces harmful brain amyloid plaques in …

Although the causes of Alzheimer's disease are still unknown, it is clear that the disease commences with progressive amyloid deposition in the brains of affected persons...

Read more

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]