Update: June 30, 2021
Asparaginase Erwinia Chrysanthemi (Erwinaze) continues ot be in short supply, however the FDA has approved an alternate drug that is as effective in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment. The FDA has issued the following new release:
- Immiate Release: J
Today, the U.S. Food and Drug Administration approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment. The only other FDA-approved drug for such patients with allergic reactions has been in global shortage for years.
“It is extremely disconcerting to patients, families and providers when there is a lack of access to critical drugs for treatment of a life-threatening, but often curable cancer, due to supply issues,” said Gregory Reaman, M.D., associate director for pediatric oncology in the FDA’s Oncology Center of Excellence. “Today’s approval may provide a consistently sourced alternative to a pivotal component of potentially curative therapy for children and adults with this type of leukemia.”
Acute lymphoblastic leukemia occurs in approximately 5,700 patients annually, about half of whom are children. It is the most common type of childhood cancer. One component of the chemotherapy regimen is an enzyme called asparaginase that kills cancer cells by depriving them of substances needed to survive. An estimated 20% of patients are allergic to the standard E. coli-derived asparaginase and need an alternative their bodies can tolerate.
Rylaze’s efficacy was evaluated in a study of 102 patients who either had a hypersensitivity to E. coli-derived asparaginases or experienced silent inactivation. The main measurement was whether patients achieved and maintained a certain level of asparaginase activity. The study found that the recommended dosage would provide the target level of asparaginase activity in 94% of patients.
The most common side effects of Rylaze include hypersensitivity reactions, pancreatic toxicity, blood clots, hemorrhage and liver toxicity.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Health Canada, where the application review is pending.
Rylaze received Fast Track and Orphan Drug designations for this indication. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need. Orphan Drug designation provides incentives to assist and encourage drug development for rare diseases.
The FDA granted approval of Rylaze to Jazz Pharmaceuticals.
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.
Asparaginase Erwinia Chrysanthemi (Erwinaze) continues ot be in short supply, see below:
Asparaginase Erwinia Chrysanthemi (Erwinaze)
Status: Currently in Shortage
»Date first posted: 10/14/2016
»Therapeutic Categories: Hematology; Oncology; Pediatric
Jazz Pharmaceuticals, Inc. is currently showing “Available” with a “Dear Health Care Provider Letter” listing requirements for special handling due to Possible Particulate Matter in Vials.
Date: July 12, 2020 7:13 AM
Asparaginase Erwinia: The U.S. Food and Drug Administration’s most recent list of drug availabilities says it is out of stock. Many major hospitals are reporting shortages. If the drug, manufactured by Jazz Pharmaceuticals (800 520-5568), is missed, it can’t simply be given when it is available. It can only be resumed later, depending on the other drugs that are part of the child’s treatment plan. The shortages have persisted across North America. For over two years there have been supply problems with this drug used to treat certain children with ALL who are not able to take the E. coli bacterium version of asparaginase used in most patients. “A recent study suggests that certain children with acute lymphoblastic leukemia who skip even one treatment of erwinia asparaginase may have lower survival rates than those who didn’t miss a treatment”.
Here is an article from November 2019 covering the shortages in Ottawa then: https://ottawacitizen.com/…/two-children-miss-cancer-treatm…
Jazz Pharmaceuticals states “the earliest we expect having product available for ordering is the week of August 3, 2020.”
Senators Susan Collins, R-ME and Tina Smith D-MN, in addressing drug shortages, have introduced S. 2723 Mitigating Emergency Drug Shortages Act. Vincristine was also in short supply from September 2019 until January 2020. Information on the bill is available here: https://wp.me/P2TETU-1LK
Date: February 1, 2020 7:30 am FDA reports that vincristine shortage has been resolved.
Date: November 18, 2019, 7:30am
The MEDS Act, S. 2723, introduced two weeks ago by Senators Susan Collins, and Tina Smith will provide additional authority to the FDA to help mitigate drug shortages and develop incentives to help ensure stable supplies of such vital medications as vincristine. Children can not afford to be without life-saving meds. Information on the Act, details, text, and endorsement form are all available here: S. 2723
November 18, 2019: Teva announced that it intends to resume manufacturing vincristine in one of it’s US locations. It is anticipated supplies will be available in early 2020.
October 31, 2019: FDA issued a report on drug shoartages: Report | Drug Shortages: Root Causes and Potential Solutions
The report examines the underlying factors responsible for drug shortages and recommends enduring solutions. It identifies three root causes for drug shortages and also recommends three enduring solutions to address drug shortages. In addition, the report describes legislative proposals in the President’s FY2020 Budget and planned FDA initiatives to prevent and mitigate shortages in the future.
10/24/19: Information from Children’s Oncology Group on Vincristine. Dr. Peter Adamson, Chair of the Children’s Oncology Group (COG) stated in a special Webinar, October 23, 2019 on Vincristine shortages stated that any child that is not getting vincristine who needs it, would be able to receive it. Pfizer has a supply for emergency shipment to those in need. A special phone number has been created and is being distributed to all 200+ COG hospitals. The special Pfizer phone number will be restricted to hospitals use only. COG hospitals treat over 90% of children who receive vincristine and other chemotherapies. All oncologists who are treating children in a non-COG affiliated hospital and do not have vincristine available will be able to contact Pfizer by contacting the Children’s Oncology Group.
If you would like to see the Webinar that took place on 10/23/2019 CLICK HERE
Webinar on Vincristine and childhood cancer drug shortages, attended by over 400 interested people, was held on October 23, 3:00pm. The Alliance for Childhood Cancer and the Coalition Against Childhood Cancer invited members of the two coalitions and the general public to an informational webinar presented by Dr. Peter Adamson, Chair of the Children’s Oncology Group. Dr. Adamson shared information the COG has received along with a perspective on childhood cancer drug shortages, including the current situation with vincristine. This webinar was held so that the community will have a better understanding of the shortage, how to work with care providers, how to contact the FDA when problems arise from the shortage, and advocacy steps being taken.
Letter to Childhood Cancer Community regarding vincristine shortage from Pfizer Inc. Hospital Division
Shipments of vincristine will be arriving late October, 2019 for both sizes. Product short supply period expected to be over by January 2020 for 1 mg/mL Single Dose Glass Fliptop Vial (NDC 61703-0309-06) and December, 2019 for 2 mg/2 mL (1 mg/mL) Single Dose Glass Fliptop Vial (NDC 61703-0309-16)
From the FDA
“New Availability information for vincristine is posted on the FDA Drug Shortage website and will be updated as additional information becomes available. Please know that we understand how critical this drug product is and we will do all that we can, within our authority, to help the manufacturer have product more readily available. Thank you.”
Click here to be directed to the FDA Drug Shortage Website
Letter to Childhood Cancer Community regarding vincristine shortage from Children’s Oncology Associates
October 15, 2019: Sound Off
Would you like to tweet members of the government to let them know how big this problem is for you and your family? Here’s a sample tweet. There is enough room at the bottom to add your Representative and Senators.
We need to solve the #VincristineShortage at once. #ChildhoodCancer kids need it now! @SecAzar @FDACommissioner @NIHDirector @NCIDrDougLowy @POTUS @SpeakerPelosi @GOPLeader @senatemajldr @SenSchumer @FrankPallone @RepGregWalden @SenAlexander @PattyMurray