Navigation Links
FDA Approves Adcetris to Treat Two Types of Lymphoma
Date:8/19/2011

SILVER SPRING, Md., Aug. 19, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Lymphomas are cancers of the lymphatic system. Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.

Adcetris is to be used in patients with HL whose disease has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant. Autologous stem cell transplant is a procedure using a patient's own bone marrow that is designed to repair damaged bone marrow after the use of high chemotherapy doses. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment.

"Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

According to the National Cancer Institute (NCI), common symptoms of HL include the enlargement of lymph nodes, spleen, fever, weight loss, fatigue, or night sweats. NCI estimates that 8,830 new cases of HL will be diagnosed in the United States in 2011 and about 1,300 people will die from the disease.

Systemic ALCL is a rare malignant tumor (non-Hodgkin lymphoma) that may appear in several parts of the body including the lymph nodes, skin, bones, soft tissue, lungs or liver, according to the NCI.

Adcetris is the first new FDA-approved treatment for HL since 1977 and the first specifically indicated to treat ALCL.

The effectiveness of Adcetris in patients with HL was evaluated in a single clinical trial involving 102 patients. In the single-arm trial, patients were only treated with Adcetris. The study's primary endpoint was objective response rate, the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment. Seventy-three percent of patients achieved either a complete or partial response to the treatment. On average, these patients responded to the therapy for 6.7 months.

The effectiveness of Adcetris in patients with systemic ALCL was evaluated in a single clinical trial in 58 patients. In the single-arm trial, patients were only treated with Adcetris. Similar to the HL trial, the trial's primary endpoint was objective response rate. Of the patients receiving Adcetris for ALCL, 86 percent experienced either a complete or partial response and responded on average for 12.6 months.

The most common side effects experienced with Adcetris were a decrease in infection-fighting white blood cells (neutropenia), nerve damage (peripheral sensory neuropathy), fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and low blood platelet levels (thrombocytopenia).

Pregnant women should be aware that Adcetris might cause harm to their unborn baby.  

The drug is being approved under the FDA's accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs, but the company will be required to submit additional clinical information after approval to confirm the drug's clinical benefit.

Adcetris is marketed by Seattle Genetics of Bothell, Wash.

For more information:

FDA: Office of Oncology Drug Products
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

NCI: Hodgkin lymphoma
http://www.cancer.gov/cancertopics/types/hodgkin

NCI: Non-Hodgkin lymphoma
http://www.cancer.gov/cancertopics/types/non-hodgkin

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.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... Incretin Mimetics/GLP-1 Agonists, SNDRIs, Lipase Inhibitors, Serotonin Receptor Agonists, ... anti-obesity drugs market is expected to grow at a CAGR ... CAGR of 38.7% in the second half of the forecast period. ... from 2016 to 2027. The market is estimated at $1,058 million ... ...
(Date:1/19/2017)... , January 19, 2017 ... European Oncology & Haematology, 2016;12(Suppl 2):3-8; http://www.touchoncology.com/articles/optimising-clinical-outcomes-gastrointestinal-cancers-through-inhibiting-angiogenesis-and ... ... Published recently in a supplement ... journal from touchONCOLOGY, an article by James ...
(Date:1/19/2017)...   Science Exchange , the leading marketplace ... the first five replication studies from the ... in eLife today. Despite intense scrutiny around reproducibility ... evaluation of reproducibility rates that may identify specific ... assessments of reproducibility, the results of this project ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... January 20, 2017 , ... Michael and Betsy Brauser celebrated ... Institute. For Betsy, the clinical trial has been life-saving as she has been ... , Betsy Brauser was diagnosed with ovarian cancer in 2009. She underwent standard ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... “Mary Magdalene: ... the mysterious life of the woman who witnessed Jesus Christ firsthand. “Mary Magdalene: Grace ... denizen, who spent her career as an educator interacting with countless women who had ...
(Date:1/20/2017)... ... , ... “I Forgive You”: a fine examination of how God handles sin, including how ... published author, Stephen Miller, who, for over ten long years has been waiting to release ... Trinidad and Tobago, he has been serving the Lord for over twenty years, and he ...
(Date:1/20/2017)... ... ... to Christmas:” a beautiful and enchanting tale that teaches children the true meaning of Christmas. ... in Oklahoma City, and a devoted woman of faith. , “Becoming a parent changes ... back of my mind for years, but actually doing it might have been a while ...
(Date:1/20/2017)... ... ... “God's Miracle Man: Against All Odds”: an inspiring affirmation of God’s ... C. A. Tucker, son of Minister Delores Pinnock and a Jamaican native who lives ... , “While sitting up in bed, I felt a pounding headache. It was like ...
Breaking Medicine News(10 mins):