FDA approves Gleevec for children with acute lymphoblastic leukemia

 

Silver Spring, MD, USA (January 25, 2013) – The U.S. Food and Drug Administration today 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.

 

 

For more information

 

  • FDA Office of Hematology and Oncology Products:
    http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm091745.htm
  • FDA Approved Drugs: Questions and Answers:
    http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm
  • NCI: Childhood Acute Lymphoblastic Leukemia:
    http://www.cancer.gov/cancertopics/pdq/treatment/childALL/Patient
  • Children’s Oncology Group:
    http://www.childrensoncologygroup.org/

 


 

U.S. Food and Drug Administration (FDA), 25.01.2013 (tB).

MEDICAL NEWS

IU School of Medicine researchers develop blood test for anxiety
COVID-19 pandemic increased rates and severity of depression, whether people…
COVID-19: Bacterial co-infection is a major risk factor for death,…
Regenstrief-led study shows enhanced spiritual care improves well-being of ICU…
Hidden bacteria presents a substantial risk of antimicrobial resistance in…

SCHMERZ PAINCARE

Hydromorphon Aristo® long ist das führende Präferenzpräparat bei Tumorschmerz
Sorgen und Versorgen – Schmerzmedizin konkret: „Sorge als identitätsstiftendes Element…
Problem Schmerzmittelkonsum
Post-Covid und Muskelschmerz
Kopfschmerz bei Übergebrauch von Schmerz- oder Migränemitteln

DIABETES

Wie das Dexom G7 abstrakte Zahlen mit Farben greifbar macht…
Diabetes mellitus: eine der großen Volkskrankheiten im Blickpunkt der Schmerzmedizin
Suliqua®: Einfacher hin zu einer guten glykämischen Kontrolle
Menschen mit Diabetes während der Corona-Pandemie unterversorgt? Studie zeigt auffällige…
Suliqua® zur Therapieoptimierung bei unzureichender BOT

ERNÄHRUNG

Positiver Effekt der grünen Mittelmeerdiät auf die Aorta
Natriumaufnahme und Herz-Kreislaufrisiko
Tierwohl-Fleisch aus Deutschland nur mäßig attraktiv in anderen Ländern
Diät: Gehirn verstärkt Signal an Hungersynapsen
Süßigkeiten verändern unser Gehirn

ONKOLOGIE

Strahlentherapie ist oft ebenso effizient wie die OP: Neues vom…
Zanubrutinib bei chronischer lymphatischer Leukämie: Zusatznutzen für bestimmte Betroffene
Eileiter-Entfernung als Vorbeugung gegen Eierstockkrebs akzeptiert
Antibiotika als Störfaktor bei CAR-T-Zell-Therapie
Bauchspeicheldrüsenkrebs: Spezielle Diät kann Erfolg der Chemotherapie beeinflussen

MULTIPLE SKLEROSE

Multiple Sklerose: Aktuelle Immunmodulatoren im Vergleich
Neuer Biomarker für Verlauf von Multipler Sklerose
Multiple Sklerose: Analysen aus Münster erhärten Verdacht gegen das Epstein-Barr-Virus
Aktuelle Daten zu Novartis Ofatumumab und Siponimod bestätigen Vorteil des…
Multiple Sklerose durch das Epstein-Barr-Virus – kommt die MS-Impfung?

PARKINSON

Meilenstein in der Parkinson-Forschung: Neuer Alpha-Synuclein-Test entdeckt die Nervenerkrankung vor…
Neue Erkenntnisse für die Parkinson-Therapie
Cochrane Review: Bewegung hilft, die Schwere von Bewegungssymptomen bei Parkinson…
Technische Innovationen für eine maßgeschneiderte Parkinson-Diagnostik und Therapie
Biomarker und Gene: neue Chancen und Herausforderungen für die Parkinson-Diagnose…