Children's Oncology Group Cancer Drug Shortage Update
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The Children's Oncology Group has reported a critical shortage of preservative-free methotrexate (pf-mtx), impacting treatment for children with acute lymphoblastic leukemia and other cancers. Although the FDA is working towards a near-term solution, the shortage's resolution will only be confirmed once all treatment centers have access to the necessary supply. The community's collaborative efforts underline the commitment to ensuring continuous care and treatment for affected children.
Children's Oncology Group Cancer Drug Shortage Update
- 1. Group Chair Peter C. Adamson, M.D. February 15, 2012 adamson@email.chop.edu Group Vice Chair The Methotrexate Shortage Susan Blaney, M.D. smblaney@txccc.org Chief Operating Officer Elizabeth O’Connor, M.P.H. To the Childhood Cancer Community: econnor@childrensoncology group.org I wanted to update the community on the status of the methotrexate drug Chief Administrative Officer Maria Hendricks, M.S.N, R.N. shortage. Over the past few weeks, the supply of preservative free methotrexate C.C.R.P. hendricksm@email.chop.edu (PF-MTX) reached critically low levels in the United States. This shortage may impact the care of children with acute lymphoblastic leukemia, certain lymphomas, Group Statistician James Anderson, Ph.D. osteosarcoma and select other childhood tumors. (The attached page contains a janderson@unmc.edu brief summary on PF-MTX and why it is such a critical part of treatment for our Associate Group Statistician children.) Mark Krailo, Ph.D. mkrailo@childrensoncology group.org Officials at the FDA continue to work hard to secure the methotrexate supply Group Chair’s Office needed, and based on reports earlier today, a near term solution to the shortage is The Children's Hospital of Philadelphia emerging. This indeed is very encouraging news. However, until we are confident 3501 Civic Center Blvd that every center that cares for children with cancer who require treatment with CTRB 10060 Philadelphia, PA 19104 methotrexate has drug available at their center, members of the Children’s P 215 590 6359 Oncology Group will not consider the crisis fully resolved. Based on information F 215 590 7544 provided by the FDA, we hope that this goal can be achieved in the upcoming days, Group Operations Center and certainly to no longer than one to two weeks. 440 E. Huntington Drive Arcadia, CA 91006 It is taking the combined effort of our entire community to help us assure that the P 626 447 0064 F 626 445 4334 best treatments remain available, without interruption, for children with cancer Statistics & Data Center throughout the United States. Numerous medical organizations, advocacy groups, Headquarters parents, friends, the FDA, the National Cancer Institute, industry leaders and 440 E. Huntington Drive Arcadia, CA 91006 members of Congress and Senate worked together, and continue to work together, P 626 447 0064 to find solutions that work. The remarkable way our community has responded to P 626 445 4334 this unprecedented crisis, I believe, speaks volumes about who we are. Gainesville Office 104 N. Main Street Although our efforts to fully resolve the crisis must continue, on behalf of the Suite 600 Gainesville, FL 32601 Children’s Oncology Group’s physicians, nurses, pharmacists, psychologists, P 352 273 0556 laboratory scientists and other allied health professionals, I thank everyone for their F 352 392 8162 support and commitment. The children and their families that members of the COG Omaha Office helps care for always continue to inspire us. Thank you. University of Nebraska Medical Center 984375 Nebraska Sincerely, Medical Center Omaha, NE 68198 4375 P 402 559 4112 F 402 559 7259 Peter C. Adamson, M.D. A National Cancer Institute supported clinical cooperative Chair, Children’s Oncology Group group and Equal Opportunity Affirmative Action Institutions Professor of Pediatrics & Pharmacology University of Pennsylvania School of Medicine at The Children's Hospital of Philadelphia
- 2. Children’s Oncology Group Update on the Methotrexate Shortage Methotrexate Methotrexate was a drug discovered in the 1950s. Since the 1960s, administration of methotrexate by mouth has been a cornerstone of maintenance chemotherapy for children with the most common childhood cancer, acute lymphoblastic leukemia (ALL). It was during the 1960s that we learned that injecting methotrexate into the spinal fluid (intrathecal administration) was critically important in helping to prevent the spread of leukemia to the covering of the brain and spinal cord. Thus for more than 40 years, all children with acute lymphoblastic leukemia receive intrathecal MTX as a part of their cancer treatment. In addition to ALL, administering methotrexate in very high doses has proven important for the treatment of a number of other cancers, including certain leukemias, lymphomas and bone cancer (osteosarcoma). There are essentially three forms of methotrexate currently used to treat children with cancer: oral methotrexate, intravenous methotrexate, and preservative free methotrexate. The current shortage only affects preservative free methotrexate, not oral or low dose intravenous MTX. Concerns on Utilizing Preservative Containing Methotrexate Intravenous concerns: Similar to a number of intravenous solutions, methotrexate for injection contains the preservative benzyl alcohol. In the late 1970s/early 1980s, research found that benzyl alcohol administration could produce significant, life threatening side effects in pre-term infants. This apparently resulted from the inability of pre-term infants to efficiently metabolize (remove from the body) benzyl alcohol. Older infants, children and adolescents generally do not experience any side effects when exposed to standard amounts of this preservative. There are a few reports, however, of older children who developed apparent benzyl alcohol side effects when exposed to very high intravenous doses of the preservative, such as which may occur with high dose methotrexate administration. The product label approved by the FDA has a warning that states that preservative containing MTX solutions should not be administered when prescribing high dose MTX. Intrathecal (into the spinal fluid) concerns: In the late 1970s/early 1980s, reports also emerged about the potential severe side effects of benzyl alcohol when given into the spinal fluid, including reports of paralysis. Although this risk may be rare, avoiding benzyl alcohol by using preservative free MTX has been the standard of care for many years. Thus the MTX product label also contains a warning not to administer preservative (benzyl alcohol) containing drugs into the spinal fluid. Page 2 of 3
- 3. Children’s Oncology Group Update on the Methotrexate Shortage About the Children's Oncology Group The Children's Oncology Group (childrensoncologygroup.org), a National Cancer Institute supported clinical trials group, is the world's largest organization devoted exclusively to childhood and adolescent cancer research. The Children's Oncology Group (COG) unites more than 7,500 experts in childhood cancer at more than 200 leading children's hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe in the fight against childhood cancer. COG research has turned children's cancer from a virtually incurable disease 50 years ago into one with an overall cure rate approaching 80 percent today. Research conducted by the COG is also supported through the generosity of individuals, corporations and private foundations working with The Children's Oncology Group Foundation (TheCOGFoundation.org), which enables philanthropic resources to go directly to COG's worldwide team of researchers committed to turning new discoveries into better treatments. Page 3 of 3