Over CLL - chronische lymfatische leukemie is in augustus 2013 ook een studiepublicatie verschenen die alle behandelingen - medicijnen voor CLL op een rijtje heeft gezet en uitlegt wat de voordelen en nadelen van deze medicijnen zijn. Dit volledige studierapport: Novel agents for chronic lymphocytic leukemia is gratis in te zien en geeft een duidelijk beeld van de stand van zaken bij CLL - Chronische lymfatische leukemie.

23 september 2013: Bron: Ther Adv Hematol. 2012 Aug;3(4):199-207. doi: 10.1177/2040620712445329

Bij de vele vormen van leukemie is de laatste jaren veel progressie geboekt met op receptoren of mutaties gerichte aanpak. Vorig jaar werd een studie gepubliceerd met Ofatumumab (merknaam Arzerra) bij mensen die ondanks de aanpak van fludarabine en alemtuzumab toch weer een recidief kregen. En uit die studie bleek dat ofatumumab toch weer een levensverlenging gaf te zien met een aanvaardbaar profiel van bijwerkingen. Maar ofatumumab gaf geen complete regressies te zien, maar wel levensverlenging. Zie hieronder abstract van die studie.

De FDA heeft al in 2009 ofatumumab goedgekeurd om te gebruiken als medicijn bij die patiënten die daarvoor gezien hun receptoren status en mutatieprofiel (CD20) voor in aanmerking komen en waarbij andere behandelingen geen effect meer hebben. Zie hieronder persbericht van FDA.

Hier het persbericht van de FDA gevolgd door het abstract van de studie met ofatumumab. Het volledige studierapport: Safety and efficacy of ofatumumab in patients with fludarabine and alemtuzumab refractory chronic lymphocytic leukaemia is gratis in te zien inclusief referentielijst van aanverwante studiepublicaties

The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow

FDA NEWS RELEASE

For Immediate Release: Oct. 26, 2009

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Treatment for Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.

Arzerra is approved for patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy.

CLL primarily affects people older than 50 and arises from a group of white blood cells known as B-cells that are part of the body’s immune system. Each year, about 16,000 people are diagnosed with CLL and about 4,400 people die from the disease.

Arzerra is a monoclonal antibody, a type of biotechnology product. Antibodies that occur in nature are produced by the immune system in response to invaders. Arzerra binds to a specific protein found on the surface of both normal and malignant B cells, making the cells more susceptible to immune system attack.

The product was approved under the FDA’s accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. Products may receive accelerated approval based on a surrogate endpoint, such as a reduction in the size of the tumor or decrease in the number of cancerous white cells or in an enlarged spleen or lymph nodes. These indirect measures for clinical outcomes are considered reasonably likely to predict that the drug will allow patients to live longer or with fewer side effects of a disease.

“The approval of Arzerra illustrates FDA's commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

The accelerated approval process requires further study of the drug. The manufacturer is currently conducting a clinical trial in CLL patients to confirm that the addition of Arzerra to standard chemotherapy delays the progression of the disease.

Arzerra's effectiveness was evaluated in 59 patients with CLL whose disease no longer responded to the available therapies.

The product’s safety was evaluated in 181 patients in two studies in patients with cancer. Common side effects included a decrease in normal white blood cells, pneumonia, fever, cough, diarrhea, lower red blood cell counts, fatigue, shortness of breath, rash, nausea, bronchitis and upper respiratory tract infections.

The most serious side effects of Arzerra are increased chance of infections, including progressive multifocal leukoencephalopathy (PML), a brain infection that is generally fatal. Patients at high risk for Hepatitis B should be screened before being treated with Arzerra. Patients with evidence of inactive hepatitis should be monitored for re-activation of the infection during and after completing treatment.

Arzerra is manufactured by London-based GlaxoSmithKline.

Safety and efficacy of ofatumumab in patients with fludarabine and alemtuzumab refractory chronic lymphocytic leukaemia.

2012 Aug;3(4):199-207. doi: 10.1177/2040620712445329.

Safety and efficacy of ofatumumab in patients with fludarabine and alemtuzumab refractory chronic lymphocytic leukaemia.

Dyer MJ.

Source

Professor of Haemato-Oncology and Honorary Consultant Physician, Department of Cancer Studies and Molecular Medicine, Leicester University, Hodgkin Building Room 405, Lancaster Road, Leicester LE1 9HN, UK.

Abstract

There are now many therapeutic CD20 monoclonal antibodies undergoing clinical trials for B-cell malignancy and autoimmune conditions; which is optimal for cancer therapy is not clear. The novel human IgG1 CD20 monoclonal antibody ofatumumab has shown significant activity in difficult to treat patients with chronic lymphocytic leukemia, namely those resistant or refractory to fludarabine and alemtuzumab and has now been licensed for this uncommon indication. This brief review summarizes the clinical data obtained with ofatumumab in CLL in terms of both efficacy and toxicity.

chronische lymfatische leukemie, CLL, ofatumumab