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:2/23/2017)... 2017 The top three players ... Healthcare, Koninklijke Philips N.V., and Schiller. Collectively, these companies ... market in 2015. Strong product portfolio and a monumental ... be aiding these players remain leaders in the fragmented ... in the global market are likely to focus on ...
(Date:2/23/2017)... YORK , February 23, 2017 ... end of day as four out of nine sectors finished ... one sector managed a flat closing. Major US indices were ... Composite ended the day at 5,860.63, slightly down by 0.09%; ... at 20,775.60; and the S&P 500 closed at 2,362.82, down ...
(Date:2/23/2017)... , Feb. 23, 2017   SeraCare Life ... global in vitro diagnostics manufacturers and clinical laboratories, ... "Catalyzing Implementation of NGS-Based Tests" to be hosted ... 2017 at 11am Eastern Standard Time (US). ... highlight the need for improved performance and global ...
Breaking Medicine Technology:
(Date:2/23/2017)... ... February 23, 2017 , ... The American Cleft Palate-Craniofacial Association (ACPA) is pleased ... KLS is a longtime supporter of the event. , "We are pleased that KLS ... Dr. Bob Havlik, 2017 ACPA President. "KLS Martin has a long track record of ...
(Date:2/23/2017)... Angeles, California (PRWEB) , ... February 23, 2017 ... ... Global Sports Development will host a diverse symposium on “Doping in ... of Law and Sheppard Mullin Richter & Hampton LLP. The symposium will be ...
(Date:2/23/2017)... ... February 23, 2017 , ... Healthcare Research & ... in the fight against cancer, has produced a seminal study that asked cancer ... release top-line findings in a webinar, Defining Compassionate Care Through the Voices of ...
(Date:2/23/2017)... ... February 23, 2017 , ... Curemark, LLC announced today that the Blüm ... in children aged 3-8 with Autism, is now enrolling at three new sites. These ... the United States. , “There are currently no approved drugs that address the ...
(Date:2/22/2017)... , ... February 22, 2017 , ... ... athletics. It’s enough to overwork even the sharpest brain. , Power On, a ... healthy activity without over clocking the brain. Each capsule contains Cognizin® Citicoline, a ...
Breaking Medicine News(10 mins):