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

Top 20 World Pharma News of 2016

Look back at the most prominent moments from the year 2016. We are proud to announce the 20 most popular World Pharma News from 2016, the most commonly viewed news accord...

Read more

Sanofi and Boehringer Ingelheim confirm Closing of…

Sanofi and Boehringer Ingelheim confirmed that the strategic transaction signed in June 2016, which consists of an exchange of Sanofi's animal health business (Merial) an...

Read more

Diabetes, heart disease, and back pain dominate US…

Just 20 conditions make up more than half of all spending on health care in the United States, according to a new comprehensive financial analysis that examines spending ...

Read more

FDA approves first drug for spinal muscular atroph…

The U.S. Food and Drug Administration has approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare ...

Read more

Novartis invests in next generation therapies to r…

Novartis announced today a collaboration and option agreement with Ionis Pharmaceuticals, Inc. and its affiliate Akcea Therapeutics, Inc., to license two novel treatments...

Read more

Topical treatment activates immune system to clear…

A combination of two FDA-approved drugs - a topical chemotherapy and an immune-system-activating compound - was able to rapidly clear actinic keratosis lesions from patie...

Read more

Vaccine shows promising results for early-stage br…

Deregulation and inhibition of the immune system contributes to cancer development. Many therapeutic strategies aim to re-stimulate the immune system to recognize cancer ...

Read more

Bristol-Myers Squibb announces immunotherapy clini…

Bristol-Myers Squibb Company (NYSE:BMY) today announced a new clinical research collaboration with Janssen Biotech, Inc. to evaluate the combination of Bristol-Myers Squi...

Read more

Anti-aging therapies targeting senescent cells: Fa…

It's an exciting time to be an elderly mouse. Researchers believe that by removing senescent cells (cells with a persistent damage response), which naturally accumulate w...

Read more

Novo Nordisk and Glooko partner to develop digital…

Novo Nordisk and Glooko today announced that the two companies will work together to deliver jointly-developed and branded digital health solutions for people with diabet...

Read more

FDA grants Roche's cancer immunotherapy TECENTRIQ …

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA)...

Read more

AstraZeneca and Lilly to develop second potentiall…

AstraZeneca and Eli Lilly and Company have announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is currently in...

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 ]