Update February 16, 2024

Health and Human Services  and the FTC Aiming to End Drug Shortages, Seek Info on “Opaque Drug Middlemen” Read Article Here.

Update January 13, 2024

Update December 14, 2023: The American Society of Clinical Oncology has issued a Ethical Guidance for the Practical Management of Oncology Drug Shortages. The Guide provides an ethically robust framework for dealing with frustratingly ever-present shortages of cancer drugs. Click here for copy.

If you have an urgent need, you may want to contact Angels for Change, a non profit organization that has been helping people for several years locate drugs that are in short supply.

Update December 7, 2023:While there have been no improvements in shortages since the last update on October 5th. On December 5th, the Senate Finance Committee held a hearing on Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective. The above link contains a recording of the meeting and testimony of the witnesses.  While the hearing presented an overview of the various supply chain difficulties, it did not give a comprehensive view of the unique shortage problems associated with treating children for cancer. Below is a listing of the Senate Finance Committee members. If you are a parent of a child that has been affected by the shortages, it would be a benefit to highlight to committee members to hear about your child’s situation.  We need to present the unique problems associated with cancer drug shortages and delayed childhood cancer treatments and ask for relief to solve the problems as quickly as possible.

Update November 17, 2023  ASCO Issues Guidance for Managing “Unprecedented” Cancer Drug Shortages. The American Society of Clinical Oncology (ASCO) has released guidelines on how to treat patients amid current cancer drug shortages. The guidelines were published in JCO Oncology Practice. Cancer drug shortages in the United States have “reached unprecedented levels,” according to the guideline authors. CLICK HERE to view guidelines.

Update October 5, 2023

On September 12, the Biden administration announced that the cisplatin supply had been restored to almost 100% of pre-shortage levels, and supplies of carboplatin and methotrexate were increasing.³

However, all 3 drugs were still in short supply at many cancer centers last month, according to a National Comprehensive Cancer Network (NCCN) survey.⁴ Meanwhile, shortages of vinblastine and dacarbazine have become a concern.^1-5

Additional details available here:  Cancer Drug Shortages Persist, Increasing Calls for Action

September 25, 2023

The Biden administration has taken steps to address the crisis, in some cases successfully: Doctors say that shortages of two cancer drugs, carboplatin and cisplatin, have eased significantly in recent weeks.

However, reports from children’s hospitals across the country are pointing to supply problems for two other chemotherapy drugs that are commonly used to treat pediatric cancers: vinblastine and dacarbazine. Another chemotherapy drug also often used in children, methotrexate, has been in short supply since March, and is still hard to come by.

All three drugs are used for a range of cancers but, in children, vinblastine and dacarbazine are most commonly used to treat Hodgkin lymphoma. Methotrexate is the go-to drug for acute lymphoblastic leukemia, the most common cancer in children.  NBC News/Health

September 21, 2023

The cisplatin shortage that has affected cancer centers and patients across the United States is nearly resolved, according to a statement from the Biden Administration.¹

The White House reported last week that the cisplatin supply has been restored to almost 100% of pre-shortage levels.  According to the US Food and Drug Administration’s (FDA) drug shortage database, 3 companies had cisplatin available on allocation as of September 18.² Additional supplies of cisplatin are expected to be released this month and next month.

“The Administration will continue to work through the FDA, the Department of Health and Human Services, and other agencies to address and prevent drug shortages and mitigate impacts to people facing a cancer diagnosis,” the White House said in its statement. Cancer Therapy Advisor 

June 15, 2023:

ASCO Chief Medical Officer Julie R. Gralow, MD, FACP, FASCO, urged members of Congress to take action on cancer drug shortages, which she described as the worst she has witnessed during her 30-year career in oncology.

“Eleven oncology drugs, maybe 14, are currently in shortage. Four of these — cisplatin, carboplatin, methotrexate and fludarabine — are commonly used to treat cancer in adults and children,” Gralow said during a House Energy and Commerce Health Subcommittee hearing this week. “Beyond drugs, we have experienced essential supply shortages, including glass vials, IV tubing, saline bags and more.”

“Patients worry about whether they’ll receive their next treatment, or if switching to another treatment will shorten their lives,”ASCO Chief Medical Officer Julie R. Gralow, MD

Update June 12, 2023: A FDA spokesperson told Reuters the agency is looking for temporary importation options for the drug, which has been in shortage since March.An FDA spokesperson told Reuters the agency is looking for temporary importation options for the drug, which has been in shortage since March.  In addition, the FDA said it was looking for additional temporary suppliers for two other cancer chemotherapies, cisplatin and carboplatin. It has already signed off on allowing cisplatin made by China’s Qilu Pharmaceutical to be sold in the country.   Source: REUTER

Current Drugs in Short Supply

Not all of the drugs below are specfically childhood cancer, but depending on various individual rare circumstances, could be considered by the doctor for various reasons.  * used in childhood cancers

According to the ACS ( Medscape Medical News as of May 18, 2023 ) the below oncology drugs and supportive agents as being listed in short supply:

• Carboplatin* injection used to treat triple negative breast cancer, ovarian, head, and neck cancers

• Fludarabine phosphate* injection used for treating B-cell chronic lymphocytic leukemia

• Dacarbazine injection for treatment of skin cancer

• Amifostine injection

• Azacitidine injection

• Capecitabine tablets

• Cisplatin injection*   Amid an ongoing drug shortage, the FDA is allowing the chemotherapy drug cisplatin to be imported from China

• Cytarabine injection

• Dexamethasone sodium phosphate injection

• Hydrocortisone sodium succinate injection

• Leucovorin calcium lyophilized powder for injection

• Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) injection

• Methotrexate injection*  used to treat cancers such as acute lymphoblastic leukemia in children, has been scarce since March 14.

• Pentostatin injection

• Streptozocin (Zanosar) sterile powder

Many of these drugs, such as cisplatin, are used in multiple regimens, so the issue is not limited to one specific cancer type.

Update June 12, 2023: FDA said it was looking for additional temporary suppliers for two other cancer chemotherapies, cisplatin and carboplatin. It has already signed off on allowing cisplatin made by China’s Qilu Pharmaceutical to be sold in the country.   Source: REUTERS

Update May 18, 2023: Methotrexate which is used to treat cancers such as acute lymphoblastic leukemia in children, has been scarce since March 14. Accord and Pfizer said the drug is on back order due to manufacturing delays, while Fresenius Kabi, Teva, and Hikma didn’t provide a reason. The companies estimate release dates ranging from this month to early June.

: Methotrexate Products Affected – Description

• • Methotrexate injection, Accord, 25 mg/mL, 10 mL preservative-free vial, 1 count, NDC 16729-0277-03
  • Methotrexate injection, Accord, 25 mg/mL, 2 mL preservative-free vial, 1 count, NDC 16729-0277-30
  • Methotrexate injection, Accord, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 16729-0277-35
  • Methotrexate injection, Fresenius Kabi, 25 mg/mL, 10 mL (with preservative) vial, 1 count, NDC 63323-0123-10
  • Methotrexate, Fresenius Kabi, 1 gram, vial, 1 count, NDC 63323-0122-50
  • Methotrexate injection, Hikma, 25 mg/mL, 2 mL preservative-free vial, 10 count, NDC 00143-9519-10
  • Methotrexate injection, Pfizer, 25 mg/mL, 2 mL (with preservative) vial, 5 count, NDC 61703-0350-38
  • Methotrexate injection, Pfizer, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 61703-0408-41
  • Methotrexate injection, Teva, 25 mg/mL, 10 mL preservative-free vial, 1 count, NDC 00703-3675-01
  • Methotrexate injection, Teva, 25 mg/mL, 2 mL preservative-free vial, 1 count, NDC 00703-3671-01
  • Source:  ASHP’s Drug Shortages Database

Reason for the Shortage

Accord has methotrexate injection on shortage due to manufacturing delays.

Fresenius Kabi did not provide a reason for the shortage.

Teva did not provide a reason for the shortage.Hikma did not provide a reason for the shortage.

Pfizer has methotrexate injection on back order due to manufacturing delay.

Past Shortages:

Asparaginase 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:

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.

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

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…

FDA Guidance:  Out of stock. For further information and to sign up for supply alerts by Jazz Pharmaceuticals please visit Erwinazesupply.com  https://erwinazesupply.com/

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, introduced S. 2723 Mitigating Emergency Drug Shortages Act,  however the bill died in the Senate due to lack of interest in gaining cosponsors. Vincristine was also in short supply from September 2019 until January 2020. 

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