Navigation Links
FDA Approves Erwinaze to Treat a Form of Leukemia
Date:11/18/2011

SILVER SPRING, Md., Nov. 18, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.

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

Acute lymphoblastic leukemia is a type of cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell. White blood cells help the body fight infection and are formed in the bone marrow.

Erwinaze is injected directly into the muscle three times a week and works by breaking down one of the body's protein building blocks (the amino acid, asparagine) that is present in the blood, and is necessary for the growth of all cells. Leukemia cells cannot produce this protein building block. When a patient is treated with Erwinaze the leukemia cells die. Normal human cells are able to make enough asparagine for their own needs through biosynthesis and will not be affected by treatment with Erwinaze.

"The approval of Erwinaze underscores the FDA's commitment to the approval of drugs for conditions with limited patient populations with unmet medical needs using novel trial endpoints," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

The safety and effectiveness of Erwinaze was evaluated in one clinical trial of 58 patients. Additional safety data was collected from the Erwinaze Master Treatment Protocol (EMTP), an expanded access program that enrolled 843 patients. Patients in both studies were unable to continue receiving pegaspargase or asparaginase derived from E. coli due to allergic reactions.

In the trial to support efficacy, the main outcome (endpoint) was the measurement of the proportion of patients with sustained asparaginase activity levels that correlate with better leukemia control and survival. All evaluable patients were shown to have maintained the pre-specified threshold for asparaginase activity at 48 or 72 hours after dosing.

Side effects associated with Erwinaze treatment include serious allergic reactions (anaphylaxis), inflammation of the pancreas (pancreatitis), high blood levels of liver enzymes (abnormal transaminases and bilirubin), blood clotting, bleeding (hemorrhage), nausea, vomiting and high blood sugar (hyperglycemia).

Prior to Erwinaze's approval there were two asparagine specific enzyme products – Elspar (asparaginase injection) and Oncaspar (pegaspargase) – approved by FDA to treat patients with ALL. Both of these products are E. coli derived.

Erwinaze has been designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the U.S.

Erwinaze is manufactured by EUSA Pharma Inc. of Langhorne, Pa.

For more information:

FDA: Office of Hematology and Oncology Products

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

FDA: Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

NCI: Adult Acute Lymphoblastic Leukemia

http://www.cancer.gov/cancertopics/pdq/treatment/adultALL/Patient/page1

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 New York Blood Centers HEMACORD™ for Stem Cell Transplantation
2. FDA Approves Erbitux to Treat Late-stage Head and Neck Cancer
3. FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
4. FDA Approves U.S. Market Return for octagam® Following Octapharmas Implementation of Enhanced Safety Measures
5. FDA Approves First Artificial Aortic Heart Valve Placed Without Open-Heart Surgery
6. FDA Approves First Generic Olanzapine to Treat Schizophrenia, Bipolar Disorder
7. FDA Approves Onfi To Treat Severe Type of Seizures
8. FDA Approves Longer Duration Efficacy and Safety for EUFLEXXA®
9. FDA Approves Label Update for PREZISTA® to Include 192-Week Data in HIV-1-Infected Adult Patients Starting Treatment
10. FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body
11. FDA Approves Combination Therapy Juvisync
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... SAN FRANCISCO , Feb. 11, 2016 Potrero ... system, is pleased to announce the appointment of George ... San Antonio, TX , WellMed is ... servicing over 200,000 patients and HMO members in ... founding WellMed in 1990 out of his own internal medicine ...
(Date:2/11/2016)... 2016  AfterPill.com is reporting that this week,s Centers ... all women who are at risk of unintended pregnancy ... and raises the risks of unprotected sex in particular.  ... According to the Guttmacher Institute, there are 43 million ... age, who have sex without the intention of becoming ...
(Date:2/11/2016)... 11, 2016  Proliant Biologicals is proud to announce ... (BSA) manufacturing facility.  The facility is located on the ... in Feilding. Boone , Iowa.  ... duplicate the systems in the U.S. facility, with critical ... U.S. installations.  --> Boone ...
Breaking Medicine Technology:
(Date:2/11/2016)... ... February 11, 2016 , ... Student-doctors from Western University ... Match Program Tuesday, February 9, taking one of the final steps in their ... education positions across the country. Of the 103 student-doctors who comprise the College ...
(Date:2/11/2016)... Nashville, TN (PRWEB) , ... February 11, 2016 , ... ... commercial cleaning business to a new market, and it’s the buildings of Nashville that ... much that when I needed to relocate to Nashville, there was no question that ...
(Date:2/11/2016)... ... February 11, 2016 , ... Thermi™, a ... is pleased to announce the promotions of Allison Kelly to executive vice president ... to executive vice president of North American capital sales, and Wendy Oseas to ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... ... ?" motivational speaker, trainer and author Ray Clarke poses a question as a ... fulfillment . In his book, "Being in the Being" (published by Partridge Singapore), ...
(Date:2/11/2016)... , ... February 11, 2016 , ... ... updated its hallmark resource, Infusion Therapy Standards of Practice, to include vascular visualization ... illumination with an estimated 85% share of the market, facilitates adherence to this ...
Breaking Medicine News(10 mins):